attention - trividia health · attention: risk management and ... • quality control program...

QUALITY ASSURANCE AND QUALITY CONTROL REFERENCE GUIDE

FOR MULTI-PATIENT USE FACILITIES

QUALITY ASSURANCE AND QUALITY CONTROL REFERENCE GUIDE

FOR MULTI-PATIENT USE FACILITIESInformation in This Manual is Specific for Healthcare Providers

ATTENTION: RISK MANAGEMENT AND CHIEF MEDICAL OFFICER

ATTENTION:TRUEtest™ Strips contain GDH-PQQ enzyme.

Please carefully review all critical safetyinformation and instructional

materials prior to performing patient blood glucose testing.

www.niprodiagnostics.com

1-800-803-6025 or 1-954-677-4599.

© 2011 Nipro Diagnostics, Inc. TRUE2go, TRUEtest and the Nipro Diagnostics logo are trademarks of Nipro Diagnostics, Inc. F9NPD21 Rev. 22 • F9H01-90

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T2g_QA_ManualCVR_F9NPD21r22.indd 2 12/16/11 9:20 AM

TRUE2go® Quality Assurance / Quality Control Manual

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IMPORTANT HEALTH AND SAFETY INFORMATIONWARNING!Healthcare Professionals should adhere to Standard Precautions and disinfection procedures when handling or using this device for testing. ALL parts of the TRUE2go Blood Glucose Monitoring System are considered potentially infectious, and capable of transmitting blood-borne pathogens.1,2 Only auto-disabling, single-use lancing devices may be used with this device. For more information on Standard Precautions and practices please refer to http://www.cdc.gov/biosafety/publications/bmbl5.

WARNING!• NEVERreuseTestStrips.NEVERwipeTestStripswithwater,alcohol,or

anycleaner.DO NOTattempttoremovebloodorcontrolsamplefromTestStripsorcleanTestStripsandre-use.ReuseofTestStripswillcauseinaccurateresults.

• NEVERaddaseconddropofsampletoStrip.Addingmoresamplegivesanerrormessage.

CAUTION!Point-of-care blood testing devices such as blood glucose meters should be used only on one patient and not shared. If dedicating blood glucose meters to a single patient is not possible, the meters must be properly cleaned and disinfected after every use following the guidelines found in Meter Care, Cleaning/Disinfection.

We suggest cleaning and disinfecting the Meter after each use to prevent the transmission of blood-borne pathogens. Healthcare Professionals should wear gloves when cleaning and disinfecting the Meter. Wash hands after taking off gloves. Contact with blood presents a potential infection risk. A new pair of gloves should be worn before testing each patient.

We recommend one meter per patient. We suggest to clean and disinfect Meterbetween patients when Meter is used on multiple patients.

Note: Clean to remove blood or soil from the surface of your Meter and disinfect to destroy infectious agents on the surface of Meter after each use.

• TocleananddisinfectMeter,usePDISuperSani-ClothGermicidal Disposablewipes(activeingredients-55%Isopropyl alcohol/Isopropanol,5,000ppm(PartsPerMillion)quarternary ammoniumchlorides)Viraguard/Viraholdwipes(activeingredient- 70%Isopropylalcohol/Isopropanol)ordisinfectantswithidentical activeingredientsfrom www.epa.gov/oppad001/list_d_hepatitisbhiv.pdf. Pleasefollowthepreparedwipesproductlabelmanufacturer’s instructionsforcleaninganddisinfectingtheMeter.• NeverputMeterinliquidsorallowanyliquidstoentertheTest Ports.• LetMeterairdrythoroughlybeforetesting.• Pleasedisposeofwipesaftercleaning/disinfecting.• Washhandsaftertakingoffgloves.• Useanewpairofglovesbeforetestingeachpatient.

Note: For more information on the PDI wipes, visit www.pdipdi.com or for information on Viraguard wipes, visit www.veridien.com.

T2g_QA_ManualTXT_F9NPD21r22.indd 1 12/30/11 10:08 AM

Safety NoticeATTENTION: Pharmacy Staff, Nursing Staff, Laboratory Staff, and Central

Supply Staff – Reminder of Potential for Falsely Elevated Blood Glucose Results due to Drug Interferences

ThisSafetyNoticeisforpersonnelinvolvedintheissuanceofpoint-of-carebloodglucosetestingsystemsandpersonnelinvolvedinactualpoint-of-carebloodglucosetesting.Parenterallyadministereddrugscontainingormetabolizingtomaltoseorgalactose,andorallyadministeredxylosecancausefalselyhighbloodglucoseresultswithcertainpoint-of-carebloodglucosemonitoringsystemsthatutilizetheenzymeglucosedehydrogenase-PQQ(GDH-PQQ)forthemeasuringofabloodglucoseresult.

Please note: The interferences described in this Notice may be seen with all blood glucose monitoring systems that use GDH-PQQ methodology, regardless of the manufacturer of the system.

TheinformationregardingthelimitationsofusingGDH-PQQmethodologymayormaynotbeincludedinthelabelingofdrugscontainingormetabolizingmaltose,galactose,orxylose.Itisimportantthatall staffareawareofthisinterferenceinordertopreventinappropriatetreatmentbasedonfalselyelevatedbloodglucoseresults.Staffmustadviseat-riskpatientswhousebloodglucosemonitoringsystemswithGDH-PQQmethodologyoftheserisksandtheconsequencesofinappropriatetreatment.

Who is at risk?

Patientsatriskforfalselyelevatedbloodglucoseresultsincludethoseusingbloodglucosemonitoringsystemsutilizingglucosedehydrogenase-PQQ,andwhoare:

• Peritonealdialysispatientsreceivingdialysissolutionscontaining icodextrin(e.g.Extraneal®,Icodial®)thatismetabolizedtomaltose;• Receivinginjectionsorinfusionsofsolutionscontaininggalactoseor maltose(includingsomehumanimmunoglobulinpreparations (e.g.Octagam®,WinRho®,SDFLiquid,HepaGamB™);• Patientsundergoingxyloseabsorptiontesting;• Patientsreceivingintravenoussolutionscontainingmaltoseasa substituteforglucoseorasameansforpatienthydration;• Patientsreceivinganydrugs,includinganyinvestigationaldrugsand thosemadebycompoundingpharmacies,whichcontainor metabolizetomaltose,galactose,orxylose(Orencia®,Adept®, Bexxar®).

Note: An At-Risk Patient Identification Notice located under Forms, Section 10, in this Manual may be used for easy identification of at-risk patients.


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Nipro Diagnostics, Inc Blood Glucose Monitoring Systems Using GDH-PQQ • TRUEresult®/TRUEtest™BloodGlucoseTestStrips• TRUE2go®/TRUEtest™BloodGlucoseTestStrips

What causes these interferences?

TheGDH-PQQmethodologydoesnotdistinguishbetweenmaltose,galactose,xylose,andglucosewhenmeasuringbloodglucose.Maltose,galactose,andxylosearenotnormallyfoundintheblood,butcanbefoundwiththeadministrationofcertaindrugs.Whenpresentintheblood,thesesubstancescanfalselyincreasethebloodglucoseresulttoaclinicallysignificantlevel.Afalsehighglucoseresultmayleadtoininappropriatetreatment,suchastheinjectionofinsulin,whichcouldleadtoahypoglycemiccomaanddeath.

Actions required:

• Beawareofthedrugsused(includinganyinvestigationaldrugsand thosemadebycompoundingpharmacies)thatcontainormetabolize maltose,galactose,orxylose,• Atpatientadmission/presentationandperiodicallythroughoutthe patient’sstayatthefacility,assessthepresenceanduseoftherapies containinginterferingdrugs,• Consultwiththepharmacistformoreinformationonwhichdrugshave beenorwillbeadministeredtothepatient,• Identifyandflagfilesorrecordsofat-riskpatients,• Iftherearepre-printorderssetsforpatientsreceivinginterferingdrugs, includeaprescriptiontotestbloodglucoseusinglaboratorymethods,• Useonlylaboratorymethodsformonitoringbloodglucoselevelsin patientsreceivinginterferingdrugs,• Establishfacilityprotocolstoverifypoint-of-care(bedside)blood glucoseresultswithlaboratoryresultsforpatientswhoareunresponsive orunabletocommunicate,• Ensurethatprotocolsfortestingadequatelyaddresstheissuewhenthe patienthistoryisunknown,• Ifyourfacilityprovidesabloodglucosemonitoringsystemforuseat homeforanat-riskpatient,instructthepatientnottouseabloodglucose monitoringsystemthatutilizesGDH-PQQ,includingtheTRUE2goand TRUEresultSystems,• Afterdrugtreatmentiscompleted,ensurethatuseofabloodglucose monitoringsystemthatutilizesGDH-PQQisclearedbytheDoctoror HealthcareProfessionalbeforeuse.

File this Safety Notice for future reference.

Questions?IfyouhaveanyquestionsregardingtheinformationcontainedinthisSafetyNotice,pleasegotowww.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm154213.htm.orcallforassistanceusingthenumberonthefrontcoveroftheManual.


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4

Introduction

NiproDiagnostics,Inc.isproudtopresenttheTRUE2goBloodGlucoseMonitoringSystem.TheTRUE2goisano-codingsystem,whichmeanstheMeterdoesnothavetobecodedtoeachlotofteststrips.TheQualityAssurance/QualityControlManualisdesignedforusespecificallybytheHealthcareProfessionalforpoint-of-caretestinginamulti-patient,multi-usersetting.HealthcareProfessionalsinyourfacilitynowhaveaverysimpleandaccuratewaytosafelytestbloodglucoselevelsinyourpatients.

NiproDiagnostics,Inc.recognizestheimportanceofpracticingsafeandreliabletestingusingtheTRUE2goBloodGlucoseMonitoringSystem.Therefore,thisManualhasbeendesignedtoprovidethefollowing:

• AbasicunderstandingoftheTRUE2goSystem,• Adetailedtestingguide,• QualityControlProgramrecommendationsfortheTRUE2goSystem inyourfacility,• Acompleteguidetotroubleshootingissuesandconcernsthatmay arisewithusingwiththeTRUE2goSysteminpatientcare,• AcomprehensivecertifiedtrainingprogramforHealthcare ProfessionalsthatwillbeusingtheTRUE2goSystem.

CAUTION!

Please read this entire Manual and all product Instructions for Use before testing. Operators of the TRUE2go Blood Glucose Monitoring System must be trained per the Training Certification Program, Section 8, prior to using the product.

CAUTION!

DO NOT change patient medication, diet, or exercise routine without consulting the patient’s Doctor or Diabetes Healthcare Professional.

Use of TRUE2go in a manner not specified in this Manual is not recommended and may affect the ability to determine true blood glucose levels.

Ourgoalistoprovidequalityhealthcareproductsanddedicatedcustomerservice.ForquestionsabouttheTRUE2goproducts,visitourwebsiteatwww.niprodiagnostics.com.


Table of ContentsSafety Notice .........................................................................................................................................1-3Introduction ............................................................................................................................................ 4Table of Contents .................................................................................................................................... 5Section 1: Using TRUE2go in a Clinical Setting

CriticalSafetyInformation/ImportantInformation/Limitations/ExpectedResults.................... 7-9RegulatoryRequirements-CLIA...........................................................................................................10ProficiencyTestingInformation............................................................................................................11MeterSpecifications.................................................................................................................................12MaterialSafetyDataSheets(MSDS)................................................................................................13-18

Section 2: Description of SystemMeter...........................................................................................................................................................20TRUEtestTestStrips..........................................................................................................................20-21TRUEtestGlucoseControlSolution......................................................................................................22Attaching/RemovingTRUE2goMetertoTRUEtestTestStripVial..............................................23

Section 3: Quality Control TestingAutomaticSelf-Test..................................................................................................................................25ControlTest...............................................................................................................................................25HowtoPerformaControlTest........................................................................................................26-27

Section 4: Blood Glucose TestingSampleInformation............................................................................................................................29-30ObtainingaBloodSample.......................................................................................................................30

TipsforFingertipSampling..............................................................................................................30TipsforForearmSampling.........................................................................................................30-31

HowtoPerformaBloodTest...........................................................................................................31-32SystemOutofRangeWarningMessages..............................................................................................32

Section 5: MemoryMemory,ViewingMemory.....................................................................................................................34

Section 6: Care, Cleaning/Disinfection and Storage of SystemSystem(MeterandTestStrips)...............................................................................................................36MeterCare,Cleaning/Disinfection........................................................................................................36TRUEtestTestStrips................................................................................................................................37TRUEtestGlucoseControlSolution......................................................................................................37BatteryReplacement.................................................................................................................................38

Section 7: TroubleshootingTroubleshooting........................................................................................................................................40DisplayMessages......................................................................................................................................41

Section 8: Training Certification ProgramCertificateInformation......................................................................................................................43-44TrainingChecklist..............................................................................................................................45-46TrainingWrittenTest........................................................................................................................47-51TrainingCertificate(example)................................................................................................................52

Section 9: FormsQualityControlLog............................................................................................................................54-55At-RiskPatientIdentificationNotice....................................................................................................56

Section 10: TRUE2go Lifetime WarrantyTRUE2goLifetimeWarranty..................................................................................................................58

Section 11: ReferencesReferences..................................................................................................................................................60


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Section 1:

Using TRUE2go® in a Clinical Setting


TRUE2go® Quality Assurance / Quality Control ManualCritical Safety Information / Important Information / Limitations / Expected Results

WARNING!TRUEtest Blood Glucose Test Strips utilize glucose dehydrogenase-PQQ (GDH-PQQ). The TRUE2go System MUST NOT be used for the following patient conditions:

• Peritonealdialysispatientsreceivingdialysissolutionscontaining icodextrin (e.g. Extraneal®, Icodial®) that is metabolized to maltose,• Injectionorinfusionofsolutionscontaininggalactoseormaltose, including some human immunoglobulin preparations (e.g. Octagam®, WinRho®, SDF Liquid, HepaGam B™),• Patientsundergoingxyloseabsorptiontesting,• Patientsreceivingintravenoussolutionscontainingmaltoseasa substitute for glucose or as a means for patient hydration,• Anydrugs,includinganyinvestigationaldrugsandthosemadeby compounding pharmacies, which contain or metabolize to maltose, galactose, or xylose (Orencia®, Adept®, Bexxar®).

Using the TRUE2go System for testing patients with the above conditions may result in falsely high glucose results. A falsely elevated glucose result may cause a patient or healthcare professional to take inappropriate steps to bring the blood glucose in normal range, including giving insulin. The inappropriate use of insulin could lead to unconsciousness, severe hypoglycemic coma and possible death. More information may be found in the TRUEtest Test Strip Instructions for Use or at www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm154213.htm3

Limitations• PleasereadallproductInstructionsforUsecarefullybefore referencingorusingthisManual.• UseonlyTRUEtestBloodGlucoseTestStripsandTRUEtestGlucose ControlSolutionwhentestingwiththeTRUE2goMeter.• DonotleaveTestStripswherethestoragetemperatureprintedonvial labelmaybeexceeded(car,trunk,briefcase,etc.).• PerformGlucoseControlTestsbeforeperformingabloodglucose test(SeeQuality Control Testing, Section 3)whenusingtheSystem forthefirsttime.ThreelevelsofTRUEtestGlucoseControlSolution areavailableforQualityControlTesting.Contactyourdistributorto orderdifferentlevelsofGlucoseControlSolution.Werecommend testingatleast2levelsofControl.Fortestingfrequencyandthe numberofControllevelstotest,refertoyourfacilityqualitycontrol procedure/policy.• TRUE2goisanin vitroquantitativesystemthatisusedforself testingandpoint-of-caretestingofhumanwholebloodonly.

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8

• Themostaccurateresultsareobtainedusingfresh,capillarywhole bloodfromthefingertip.VenouswholeblooddrawninEDTA (purpletoptube)orheparin(greentoptube)maybeusedfortesting. Mixtubecontentsgentlybeforeusing.Usevenousbloodwithin30 minutesafterdrawing.Serum,clottedblood,orplasmacannotbe usedwiththeTRUE2goSystem.• Capillarybloodfromtheforearmmaybeused.Checkwiththe DoctororHealthcareProfessionaltoseeifforearmtestingmaybe usedforglucosetestingonthepatient.Resultsfromtheforearmare notalwaysthesameasresultsfromthefingertip.Usefingertip insteadofforearm:

- Within2hoursofeating,exercise,ortakinginsulin,- Ifthepatient’sbloodglucosemayberisingorfallingrapidlyor

theirresultsoftenfluctuate,- Ifthepatientisillorunderstress,- Iftheglucoseresultmaybeloworhigh,- Ifsymptomsofloworhighglucoselevelsarenotevident.4

• ForevaluationorQualityControlprocedureswhereTRUE2goblood glucosevaluesarecomparedtobloodglucosevaluesgivenbya laboratory,itisrecommendedthatcapillaryorvenouswholeblood obtainedfromthesamesitebeusedforboththelaboratory instrumentaswellastheTRUE2goSystem.Laboratorytestsshould beperformedwithin30minutesofabloodglucosemetertestto minimizethechangesinglucosevaluesduetoglycolysis.Results fromtheTRUE2goSystemareconsideredaccurateifwithin+20% oflaboratoryresults.5Ifpatienthasrecentlyeaten,fingerresults fromtheTRUE2goSystemcanbeupto70mg/dLhigherthan venouslaboratoryresults.6• TheTRUE2goSystemcannotbeusedinthediagnosisofdiabetesor totestbloodglucoseinnewborns.• DONOTperformcapillarybloodglucosetestingoncriticallyill patients.Capillarybloodglucoselevelsincriticallyillpatientswith reducedperipheralbloodflowmaynotreflectthetruephysiological state.Reducedperipheralbloodflowmayresultfromthefollowing conditions(forexample):7• shock• severehypotension• severedehydration• hyperglycemiawithhyperosmolarity,withorwithoutketosis• Testingataltitudesuptoandincluding10,150feetwillnotaffect accurateresults.5• Hematocritlevelsbetween20%and60%willnotaffectaccurate results.5


Expected Results

EachpatientshouldhavespecificbloodglucosetargetrangesthataredeterminedbytheDoctororDiabetesHealthcareProfessional.Havingmostbloodglucoseresultswithinthepatient’stargetrangeshowshowwellatreatmentplanisworkingtocontrolglucoselevels. Keepingresultswithinthepatient’stargetrangehelpssloworstopcomplicationsfromdiabetes.

ExpectedResultsforpeoplewithoutdiabetes:8

PlasmaBloodGlucoseResultBeforeeating <110mg/dLTwohoursaftermeals <140mg/dL

• Lowbloodglucose(hypoglycemia)symptomsmayinclude trembling,sweating,intensehunger,nervousness,weaknessor troublespeaking.• Highbloodglucose(hyperglycemia)symptomsmayincludeintense thirst,aneedtourinateoften,adrymouth,vomiting,orheadache.

Ifthepatientisshowinganyofthesesymptoms,checktheirbloodglucose.Ifanyresultseemshigherorlowerthanexpected,repeatthetestwithanewTestStrip.ContacttheDoctororDiabetesHealthcareProfessionalwithanyunusualresults.


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Regulatory Requirements - CLIA

Self-testingandpoint-of-caretestingofbloodglucosehasbeenclassifiedbytheClinicalLaboratoryImprovementAmendments(CLIA)asawaivedtest.CLIArequiresallentitiesthatperformevenonetest,includingwaivedtests,[onmaterialsderivedforthehumanbodyforthepurposeofprovidinginformationforthediagnosis,preventionortreatmentofanydiseaseorimpairmentof,ortheassessmentofthehealthof,humanbeings]tomeetcertainFederalrequirements.Ifanentityperformstestsforthesepurposes,itisconsideredunderCLIAtobealaboratoryandmustregisterwiththeCLIAprogram.

Waivedlaboratoriesmustmeetthefollowingrequirements:

• CompletetheClinicalLaboratoryImprovementAmendmentsof1988 (CLIA)ApplicationforCertification,FormCMS-116.Theformand instructionsoncompletingandmailingtheformarefoundon http://www.cms.hhs.gov/CLIA/06_How_to_Apply_for_a_CLIA_ Certificate_Including_Foreign_Laboratories.asp#TopOfPage.• Payapplicablecertificatefeesbiennially.• Followmanufacturer’stestinstructions,includinginstructionsfor QualityControl,maintenance,andstorageinstructions.

UponapprovalofFormCMS-116,aCertificateofWaiverisforwardedtothelaboratory.

FormoreinformationontheCLIAprogram,seehttp://www.cms.hhs.gov/CLIA/.

Foracomprehensivelookatwaivedtesting,seehttp://www.cdc.gov/mmwr/preview/mmwrhtml/rr5413a1.htm.


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TRUE2go Blood Glucose Monitoring System Proficiency Testing Information

Theobjectiveofproficiencytestingistoqualitativelydeterminetheskilloftheuserofaspecificproductandtheaccuracyoftheresultsobtainedusingtheproduct.Participatinglaboratoriesreceivespecimensfromadistributor,testthespecimensandreporttheresultsbacktothedistributor.Theresultsofallparticipantsaresummarizedinareportthatissenttotheparticipatinglaboratories.Thereportcontainsanevaluationoftheindividuallaboratoryperformanceaswellasacomparisontoasummaryofresultsfromotherparticipatinglabs.

Itisimportanttobeawarethatproficiencysamplesarenotfreshbloodandmaybehavedifferentlyondifferentglucosetestsystems.Theaccuracyoftheresultfromaproficiencysampleisnotanindicatoroftheaccuracyofyoursystemwhentestedwithfreshwholebloodobtainedfromapatient.TheproficiencytestingonlyservestoshowhowyourresultscomparetootherTRUE2gosystemusers.IfyourproficiencysampleresultsarenotwithinacceptablelimitsofotherTRUE2gousers’results,thenyoushouldinvestigatepossiblesourcesoftestingerrorsuchasexpirationdateandstorageconditionsfortheteststrips.Alwaysperformqualitycontroltestingperyourfacility’sproceduresandpoliciestomakesureyoursystemisworkingproperly.TheOwner’sBookletorQAManualwillassistyouwiththisprocess.

TheTRUE2gosystemisoptimizedtogiveaccurateresultswithfresh,capillarywholebloodandvenouswholebloodsamples.VenouswholebloodsamplesmustbetestedimmediatelyorpreservedinavacutainertubecontainingEDTA(purpletop)orheparin(greentop).Thiswillpreservethesampleforapproximately30minutes.RefertotheTRUE2goOwnersBookletandTRUEtestTestStripInstructionsforUseforfurtherinformation.

ResourcestolearnaboutandobtainProficiencySamples:

CollegeofAmericanPathology(CAP)www.cap.org

AmericanAssociationofBioanalystswww.aab.org


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Meter Specifications

Result Range:20-600mg/dL

Sample Size:0.5microliters(0.5µL)

Sample Type: Freshcapillarywholebloodfromthefingerorforearm, venousblooddrawninEDTA(purpletoptube)orheparin (greentoptube)within30minutesofcollection

Test Time: Aslittleas4seconds

Result Value: Plasmacalibrated

Assay Method: Electrochemical

Reference Method: YellowSpringsInstrument(YSI)

Power Supply: One3Vlithiumbattery#CR2032(non-rechargeable) Totalpowerwhenactiveatfullbattery=8.6mW

Battery Life: Approximately1500testsor2years

Automatic Shut-off: After2minutesofnon-use

Weight: 0.6ounces

Size: 1.70”x1.46”x0.89”

Memory Size: 99results

System Operating Range (Meter and Test Strips): RelativeHumidity:10-90%(non-condensing) Temperature:50°-104°F Hematocrit:20-60% Note: Use within specified environmental conditions only.

Chemical Composition: TRUEtest Test Strips: Glucosedehydrogenase-PQQ(Acinetobacter

calcoaceticus),mediators,buffersandstabilizers TRUEtest Glucose Control Solution: Water,d-glucose,buffers,viscosity

enhancingagent,salts,dyeandpreservatives


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Material Safety Data Sheet

Section 1 : Product Information

Product Name : TRUEtest Blood Glucose Test StripsDate Prepared : 16April2008Revision Number :0

Section 2 : Composition / Information on Ingredients

Vial:SilicaGel,polypropylene,polyethyleneTest Strips:Glucosedehydrogenase-PQQ,mediators,buffersandstabilizersTest Strip Box and Package Insert:Paper

Section 3 : Hazard Identification

Nosignificantimmediatehazardsforemergencyresponseareknown.

Section 4 : Emergency First Aid Procedures

Eye: Nofirstaidrequired.Skin: Nofirstaidrequiredforcontactwithskin.Ingestion: Nofirstaidrequiredfromingestion.Inhalation: Nofirstaidrequired.

Section 5 : Fire and Explosion Hazard Data

Flash Point (Method Used): Vial->450°F(estimated),TestStrips-N/A

Flammable Limits: N/A

General Hazard: Solidmaterialmayburnatorabovetheflashpoint.Ifthermallydecomposed,flammable/toxicgasesmaybereleased.Toxicgaseswill formuponcombustion.Hazardouscombustionproductsmayincludeandarenotlimitedto:carbonmonoxide,carbondioxide.

Special Fire Fighting Procedures: Usewaterspraytocoolfireexposedsurfacesandtoprotectpersonnel.Isolate“fuel”supplytofire.Extinguishthefirebycoolingwithwaterspray.Respiratoryandeyeprotectionrequiredforfirefightingpersonnel.

Unusual Fire and Explosion Hazards: Nonedetermined.


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Section 6 : Spill or Leak Procedures

Steps to be taken in case material is released or spilled: Containmaterialtopreventcontaminationofsoil,surfacewaterandgroundwater.Maybeslippinghazard.

Section 7 : Handling and Storage

Storeattemperaturesandconditionsasindicatedontheproductlabel.Storeinoriginalcontainerandkeepvialclosed.

Section 8 : Personal Protection

Ventilation: Usegeneralroomventilation.Respiratory Equipment: NoneProtective Gloves: NoneEye Protection: NoneOther Protective Equipment/Clothing: None

Section 9 : Physical Data Appearance and odor: Vial-Vialwithdesiccantliner,TestStrips-Plasticstripwithreactionarea.

pH: N/ASpecific Gravity: N/ABoiling Point: N/AMelting Point: N/AVapor Pressure: N/AEvaporation Rate: N/ASolubility in Water: N/A

Section 10 : Reactivity Data

Stability: Stableifatstoragetemperatureandoriginalvialclosed.

Conditions to Avoid: Productcanoxidizeanddecomposeatelevatedtemperatures.Avoidputtingwaterinsideofvial,exothermicreactionwilloccur.Temperaturesabove300°Fmaycauseproductdegradationandselfcombustion.

Substances to Avoid: Avoidcontactwithstrongacidsandoxidizingmaterials.

Hazardous Decomposition Products: Flammablehydrocarbons.

Hazardous Polymerization: Willnotoccur.


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Section 11 : Toxicological Information

Chronic Effects of Overexposure: Nonecurrentlyknown.

Carcinogen or Suspected Carcinogen: Noneofthecompoundspresentarelistedasacarcinogenorsuspectedcarcinogen.

Medical Conditions Aggravated by Exposure: Nonecurrentlyknown.

Acute Toxicity Values: Notapplicable.

Section 12 : Ecological Information

Ecologicaleffectsofthisproducthavenotbeendetermined.

Section 13 : Disposal

Primary Container Type: Vialwith50teststrips.

Waste Disposal Method: Eachdisposalfacilitymustdetermineproperdisposalmethodstocomplywithlocal,state,andfederalenvironmentalregulations.


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Material Safety Data Sheet

Section 1 : Product Information

Product Name : TRUEtest Glucose Control Solution - Levels 1, 2, and 3

Date Prepared : 16April2008

Revision Number :0

Section 2 : Composition / Information on Ingredients

Bottle:Polypropylene,polyethyleneControl Solution:Water,d-glucose,buffers,viscosityenhancingagents,salts,dyes,andpreservatives.

Control Solution Box and Package Insert:Paper

Section 3 : Hazard Identification

Nosignificantimmediatehazardsforemergencyresponseareknown.

Section 4 : Emergency First Aid Procedures

Eye: Flushwithcopiousamountsofwater.Skin: Flushwithwater.Ingestion: Contactphysician.Inhalation: Contactphysician.

Section 5 : Fire and Explosion Hazard Data

Flash Point (Method Used): Bottle-N/A,ControlSolution-N/AFlammable Limits: N/AGeneral Hazard: N/ASpecial Fire Fighting Procedures: N/AUnusual Fire and Explosion Hazards: Nonedetermined.

Section 6 : Spill or Leak Procedures

Steps to be taken in case material is released or spilled: Containmaterialtopreventcontaminationofsoil,surfacewaterandgroundwater.Maybeslippinghazard.


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Section 7 : Handling and Storage

Storeattemperaturesandconditionsasindicatedontheproductlabel.Keepbottletightlyclosedwhennotinuse.

Section 8 : Personal Protection

Ventilation: Usegeneralroomventilation.Respiratory Equipment: None.Protective Gloves: NoneEye Protection: NoneOther Protective Equipment/Clothing: None

Section 9 : Physical Data Appearance and odor: Bottle-plasticbottlewithcap,ControlSolution-Redliquid.

pH: N/ASpecific Gravity: N/ABoiling Point: N/AMelting Point: N/AVapor Pressure: N/AEvaporation Rate: N/ASolubility in Water: N/A

Section 10 : Reactivity Data

Stability: Stableatstoragetemperature.Keepbottleclosedwhennotinuse.Conditions to Avoid: N/ASubstances to Avoid: Avoidcontactwithstrongacidsandoxidizingmaterials.Hazardous Decomposition Products: Flammablehydrocarbons.Hazardous Polymerization: Willnotoccur.

Section 11 : Toxicological Information

Chronic Effects of Overexposure: Nonecurrentlyknown.Carcinogen or Suspected Carcinogen: Noneofthecompoundspresentgreaterthan0.1%arelistedasacarcinogenorsuspectedcarcinogen.Medical Conditions Aggravated by Exposure: Nonecurrentlyknown.Acute Toxicity Values: Notapplicable.


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Section 12 : Ecological Information

Ecologicaleffectsofthisproducthavenotbeendetermined.

Section 13 : Disposal

Primary Container Type: Bottlewith3mLGlucoseControlSolution.

Waste Disposal Method: Eachdisposalfacilitymustdetermineproperdisposalmethodstocomplywithlocal,state,andfederalenvironmentalregulations.


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Section 2:

Description ofSystem



20

Top

Description of System

Meter

1.Set Button- Markresultasanalternatesite,turnMeteron/offforMemory,view/scrollresultsinMemory.Note: Use of Memory function is not recommended in a multi-patient setting.

2.Display Screen-Showsresults,messages,userprompts,information3.Drop Symbol4.Units of Measure (Note: Factory set, cannot be changed by user.)5.Strip Release Button-ReleasesTestStripaftertestingiscomplete.6.Test Port- PlacetoinsertTRUEtestTestStrip7.Battery Door- Opentoreplacebattery.Useonenon-rechargeable

3Vlithiumbattery(#CR2032),positive(“+”)sideup(See BatteryReplacement,Section6, for more details).

8.Meter Label- ContainsSerialNumberoftheMeterandphonenumbertocallforassistance.

Test Strip

9.Contact End-InsertintoTestPortwithTRUEtestnamefacingup.10.Sample Tip- Bringsample(fresh,capillaryorvenousbloodorGlucose

ControlSolution)toedgeofTip.Capillaryactiondraws sampleintoTestStripfortesting.

Full Display Bottom

1

2

2

3

45

6

7

8

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Sample Placement

CorrectPlacement IncorrectPlacement

• Allowsample(bloodorControl)tobedrawnintoSampleTip.

CAUTION! Holding the Test Strip to blood sample too long after the Meter begins testing may cause inaccurate results.

• DonotsmearorscrapesamplewithTipofTestStrip.• DonotapplymoresampletotheTestStripafterremovingtheTest Stripfromthesampledrop• DonotapplybloodorControltotopofTestStrip.• DonotinsertSampleTipintotheMeter.

Note: Inserting the Test Strip backwards (Sample Tip into Test Port) after sampling may cause the Meter not to turn on. If Meter does not turn on, see Troubleshooting,Section8.

Test Strip Vial Label

1.Lot Number (LOT)- UsedforidentificationoflotforQCForm, usedasareferenceifcallingforassistance.

2.Expiration Dates (EXP)- TheprintedExpirationDateislocatedontheTestStripvialnexttoEXP.Writethedatefirstopenedonviallabel.DiscardvialandunusedTestStripsifeitherdateprintedafterEXP onTestStripviallabelor4monthsafterdatewrittenonviallabelhaspassed.

3.GDH - PQQ- Enzymeusedforglucosetestingisglucosedehydrogenase-PQQ.SeeCritical Safety Information / Important Information / Limitations / Expected Results, Section 1forlimitationsofusewithpatient.

CAUTION! Use of Test Strips or Glucose Control Solution past the Expiration Dates may give incorrect test results. Discard out-of date products and test with new products.

4.Control Range- RangeofnumbersinwhichControlTestresultmustfall toassuretheSystemisworkingproperly.

12

3 4

3



22

Glucose Control Solution Bottle Label

1.Lot Number (LOT)- UsedforidentificationoflotforQCForm,usedasa referenceifcallingforassistance.

2.Expiration Dates (EXP)- TheprintedExpirationDateislocatedontheControlbottlelabelnexttoEXP.Writethedatefirstopenedonbottlelabel.DiscardbottleandunusedControlSolutionifeitherdateprintedafterEXP onControlbottlelabelor3monthsafterdatewrittenonbottlelabelhaspassed.

3.Control Level-ThreelevelsofTRUEtestGlucoseControlSolutionare available,Levels1,2,and3.Werecommendtestingat least2levelsofControl.Fortestingfrequencyandthe numberofControllevelstested,refertoyourfacility qualitycontrolprocedure/policytotest.

1

2

3



23

Attach / Remove TRUE2go Meter to TRUEtest Test Strip Vial

TheTRUE2goMeterisdesignedtoattachtothetopoftheTRUEtestTestStripvialforeaseofuse.

Attach

1. PlaceTestStripvialuprightonflatsurfacewithvialcaplipfacingfront.2. WithMeterTestPortfacingtotheright,placebottomoftheMeterfirmlyon

thevialtop.Metermustbeseatedflatonthetopofthevialcap.3. Holdingthevial,twisttheMeter¼turnclockwise.ThesectionoftheMeter

wheretheTestPortislocatedshouldcovertheviallipifattachedproperly.

4. Toopenthevial,liftupontheMeterundertheTestPort.5. Toclosethevial,pressfirmlyontheareaonthetopoftheTestPort.

Remove

1. Holdingthevial,twisttheMeter¼turncounterclockwise.2. LiftoffMeterfromvialtop.

Note: The Meter may be used for testing without attaching to the vial.

LiftUpToOpen

PressDownToClose

TestPort

VialLip


Section 3:

Quality ControlTesting



25

Quality Control Testing

QualityControlproceduresareusedtodetecterrorsthatmayoccurduetotestsystemerrors,productdefects,adverseenvironmentalconditionsandvarianceinoperatorperformance.OngoingQCproceduresarealsousedtodetectanyperformanceissuesoftheSystemovertime.FacilityQualityControlTestingPolicyandProcedureshouldadheretothemanufacturer’sinstructionsforuseandregulatoryguidelinessetforthbyappropriatestate,regionalornationallicensingoraccreditingagencies.TRUE2goisano-codingsystem,whichmeanstheMeterdoesnothavetobecodedtoeachlotofTestStrips.Toassureaccurateandreliableresults,TRUE2goofferstwokindsofQualityControlTests.ThesetestsensurethatTRUE2goisworkingproperlyandtestingtechniqueisgood.

Automatic Self Test

Anautomaticself-testisperformedbytheMetereachtimeaTRUEtestTestStripisinsertedcorrectlyintotheTestPort.AfterinsertingtheStripintotheTestPort,ifthefullDisplay(showingnomissingsegments,seeDescriptionofSystem,Section2)followedbytheDropSymbolappears,theMeterisworkingproperly.Ifanerrormessage(E-1,E-2etc.)appearsintheDisplayafterinsertingaTestStrip,theMeterwillnotperformaglucosetest.SeeDisplayMessages,Section8formoreinformationonerrormessages.

CAUTION! If any segments are missing in the Display when the Test Strip is inserted into the Test Port, do not use the Meter for testing. Call for assistance using the phone number on the QA/QC Manual cover.

Control Test

UseONLYTRUEtestGlucoseControlSolutiontochecktheperformanceoftheSystem.ItisimportanttoperformControlTestswithmorethanonelevelofControltoassurethattheSystemisworkingproperlyandtestingtechniqueisgood.ThreelevelsofTRUEtestGlucoseControlSolution(Levels1-3)containingknownamountsofglucoseareavailable.CallthephonenumberontheQA/QCManualcoverorcontactyoursuppliertoorderdifferentlevelsofControlSolution.ControlTest(s)shouldbeperformed:

• BeforeusingtheSystemforthefirsttime,• Forpracticetoensurethattestingtechniqueisgood,• WhenopeninganewvialofStrips,• Ifresultsseemunusuallyhighorlowbasedonthepatient’scondition,• IfStripvialhasbeenleftopenorexposedtoextremeheat, coldorhumidity,• WheneveracheckontheperformanceoftheSystemisneeded,or• IfMeterdamageissuspected(Meterdropped,crushed,wet,etc.).

CAUTION! Glucose Control ranges printed on the Test Strip vial are ranges for Control Tests results only. These ranges are not to be used by patients for blood glucose management. Contact a Doctor or Diabetes Healthcare Professional for individualized blood glucose target ranges. DO NOT consume Glucose Control.

DropSymbol

FullDisplay



26

How to Perform a Control Test

UsetheQualityControlLoglocatedinForms, Section 9torecordControlTestresults.

1. AllowControlbottle,vialofTestStripsandMetertoadjusttoroomtemperature(59°-86°F).

Note: Performing a Control Test at temperatures above or below room temperature may cause the Control to read as a blood test.

2. CheckdatesonControlbottlelabelandTestStripviallabel.• DonotuseControlif3monthspastwrittenopeneddateor afterEXP dateprintedonControlbottlelabel.• DonotuseTestStrips4monthspastwrittenopeneddateor afterEXP dateprintedonTestStripviallabel.

Discardoutofdateproductsandusenewproductsifeitherdatehaspassed.

3. SwirlorinvertControlbottlegentlytomixControl.DO NOT SHAKE!

4. OpenTestStripvialbypushingupundertheTestPortoftheMeterattachedtothevial.RemoveoneTestStrip.ClosevialimmediatelybyfirmlypressingdownonthetopoftheTestPortarea.

Note: Use Test Strip quickly after removal from vial. Test Strips that have been left outside the vial too long will give an error message. If an error message appears in the Display, release and discard the old Test Strip and test with a new Test Strip.

5. WithMeteroff,inserttheTestStripContactEnd(TRUEtestnamefacingup)intotheTestPort.Meterturnson.KeeptheTestStripintheMeteruntiltestingiscomplete.

6. WaituntiltheDrop SymbolappearsintheDisplay.

Note: If Test Strip is removed before testing is finished, an error message appears. Release and discard old Test Strip. Test with new Test Strip.

7. RemovecapfromControlbottle.TurnControlbottleupsidedown.SqueezeonedropofControlontoacleantissue.Wipeoffbottletip.

8. GentlysqueezeanotherdropofControlontoasmallpieceofunusedaluminumfoil,clearplasticwrap,oraclean,nonporoussurface.(Discardfoil/wraporcleanareaafteruse.)

LB0010

9 JUNE 2009

LiftUpToOpen

PressDownToClose

DropSymbol


9. WhileTestStripisstillintheMeter,touchedgeofTestStripSampleTiptodropofControlandallowdroptobedrawnintoTestStrip.RemoveTestStripfromthedropwhendashesappearacrosstheMeterDisplay.Meteristesting.

Note: If Meter does not begin testing soon after drawing up sample (dashes appear in the Display), release and discard Test Strip. Repeat the test with a new Test Strip. If problem persists, See Troubleshooting,Section7.

10.ControlTestresultisdisplayed.ComparetheMeterresulttotheControlRangeprintedontheTestStripviallabelfortheControllevelthatisbeingtested.Iftheresultisinrange,theSystemcanbeusedfortestingblood.Iftheresultisnotwithinrange,repeatthetestusinganewTestStrip.

Note: Performing a Control Test at temperatures above or below room temperature (59° - 86°F) may cause the Control to read as a blood test.

CAUTION! If Control Test is outside of the correct range, perform test again using a new Test Strip and a new drop of Control. If the result is still outside the correct range, the System should not be used for testing blood. Call for assistance (see front cover for phone number).

11.RecordtheresultintheTRUE2goQualityControlLog(seeForms, Section9).

12.HoldtheTestStripvialwithTestStrippointingdown.PresstheStripReleaseButtontoreleaseanddiscardtheTestStripintoanappropriatecontainer.TheMeterturnsoff.


27


Section 4:

Blood GlucoseTesting



29

Blood Glucose Testing

Sample Information

Fresh,capillarywholebloodfromthefingerorforearmistherecommendedsampletobeusedfortestingbloodglucose.AlwayscheckwiththeDoctororDiabetesHealthcareProfessionalbeforeusingasamplefromtheforearm.Resultsfromtheforearmarenotalwaysthesameasresultsfromthefingertip.Usefingertipinsteadofforearm:

- Within2hoursofeating,exercise,ortakinginsulin,- Ifthepatient’sbloodglucosemayberisingorfallingrapidlyortheir

resultsoftenfluctuate,- Ifthepatientisillorunderstress,- Iftheglucoseresultmaybeloworhigh,- Ifsymptomsofloworhighglucoselevelsmaynotbeevident.4

Note: Venous whole blood drawn in EDTA (purple top tube) or heparin (green top tube) may be used for testing. Use venous blood within 30 minutes of collecting for best results. Mix tube contents gently before using. Serum, clotted blood, and plasma cannot be used with the TRUE2go System.

ForevaluationwhereTRUE2gobloodglucoseresultsarecomparedtobloodglucoseresultsgivenbyalaboratoryinstrument,itisrecommendedthatcapillaryorvenouswholebloodobtainedfromthesamesamplingsitebeusedforboththelaboratoryinstrumentaswellastheTRUE2goSystem.Laboratorytestsshouldbeperformedwithin30minutesofabloodglucosemetertesttominimizethechangesinglucosevaluesduetoglycolysis.ResultsfromtheTRUE2goSystemareconsideredaccurateifwithin+20%oflaboratoryresults.5Ifpatienthasrecentlyeaten,fingerresultsfromtheTRUE2goSystemcanbeupto70mg/dLhigherthanvenouslaboratoryresults.5

TheTRUE2goSystemcannotbeusedonnewborns.PerformlaboratoryglucoseTestsoncriticallyillpatients.

WARNING!TRUEtest Blood Glucose Test Strips utilize glucose dehydrogenase-PQQ (GDH-PQQ). The TRUE2go System MUST NOT be used for the following patient conditions:

• Peritonealdialysispatientsreceivingdialysissolutionscontaining icodextrin (e.g. Extraneal®, Icodial®) that is metabolized to maltose,• Injectionorinfusionofsolutionscontaininggalactoseormaltose, including some human immunoglobulin preparations. (e.g. Octagam®, WinRho®, SDF Liquid, HepaGam B™),• Patientsundergoingxyloseabsorptiontesting,• Patientsreceivingintravenoussolutionscontainingmaltoseasa substitute for glucose or as a means for patient hydration,


• Anydrugs,includinganyinvestigationaldrugsandthosemadeby compounding pharmacies, which contain or metabolize to maltose, galactose, or xylose (Orencia®, Adept®, Bexxar®).

Using the TRUE2go System for testing patients with the above situations may result in falsely high glucose results. A falsely elevated glucose result may cause a patient or healthcare professional to take appropriate steps to bring the blood glucose in normal range, including giving insulin. The inappropriate use of insulin could lead to unconsciousness, severe hypoglycemic coma and possible death. More information may be found in the TRUEtest Test Strip Instructions for Use or at www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm154213.htm.3

Obtaining a Blood Sample for Blood Glucose Testing

Refertoyourfacilityapprovedmethodforlancingtoobtainabloodsampleforbloodglucosetesting.FollowOSHAprecautionsforblood-bornepathogens.

CAUTION! We suggest cleaning and disinfecting the meter after each use to prevent the transmission blood-borne pathogens. Only auto-disabling, single-use lancing devices may be used with this device.

Tips for Fingertip Sampling

Note: A new pair of gloves should be worn before obtaining a blood sample. Contact with blood presents an infection risk.

1. Selectfingertip.Cleanareawithsoapandwarmwater,rinseoruseanapproveddisinfectanttocleanthearea.Drythoroughly.

2. Lancefingertip.3. Tohelpblooddropform,lowerthehandtoalevelbelowtheheartand

gentlymassagethefingerfrompalmtofingertip.AllowtheblooddroptoformbeforeattemptingtoapplytheTestStrip.

4. Discardallbiohazardmaterialsintoappropriatecontainer.Washhandsaftertakingoffgloves.

Tips for Forearm Sampling

• CheckwithyourDoctororDiabetesHealthcareProfessionaltosee if forearm testing is appropriate for the patient.

• Resultsfromtheforearmarenotalwaysthesameasresultsfrom the finger.

• Use finger for testing instead of forearm for more accurate results;- Within 2 hours of eating, exercise, or taking insulin,- If the patient’s blood glucose may be rising or falling rapidly or their

results often fluctuate,- If the patient is ill or under stress,- If the glucose result may be low or high,- If symptoms of low or high glucose levels are not evident.4


30



31

Note: A new pair of gloves should be worn before obtaining a blood sample. Contact with blood presents an infection risk.

1. Selectarea.Cleantheareawithsoapandwarmwater,rinseoruseanapproveddisinfectant.Drythoroughly.

2. Rubareavigorouslyorapplyawarm,drycompresstoincreasebloodflow.

3. Lanceforearm.

4. Discardallbiohazardmaterialsintoappropriatecontainer.Washhandsaftertakingoffgloves.

How to Perform a Blood Glucose Test

1. CheckdatesonTestStripviallabel.• DonotuseTestStrips4monthspastwrittenopeneddateor afterEXP dateprintedonTestStripviallabel.

2. Cleantheareatobelancedwithanapproveddisinfectant.Drythoroughly.

3. RemoveoneTestStripfromTestStripvialbypressingupundertheTestPortoftheMeterattachedtotheTestStripvial.CloseTestStripvialimmediatelybypressingfirmlydownonthetopoftheTestPortarea.

Note: The TRUE2go is a no-coding system, which means the Meter does not have to be coded to each lot of test strips.

Note: Use Test Strips quickly after removal from Test Strip vial. Test Strips that have been left out of the vial too long will give an error message. If error message displays, release and discard the old Test Strip and test with a new Test Strip.

4. WithMeteroff,inserttheTestStripContactEnd(TRUEtestnamefacingup)intotheTestPort.TheMeterturnson.KeeptheTestStripintheMeteruntilthetestiscomplete.

Note: Removing the Test Strip before the result is displayed cancels the test. An error message appears. Retest with a new Test Strip and do not remove the Test Strip from the Meter before the result is displayed.

5. WaituntiltheDrop SymbolappearsintheDisplay.

Note: To mark the test as an alternate site, press the Set Button.

6. Obtainthebloodsample.Allowblooddroptoform(seeObtainingaBloodSample,Section4).

LiftUpToOpen

PressDownToClose

DropSymbol



32

7. WithTestStripstillinMeter,touchedgeofSampleTiptoblooddropandallowbloodtobedrawnintoStrip.RemoveTestStripSampleTipfromsampledropimmediatelyafterdashesappearacrosstheMeterDisplay.

CAUTION! Holding the Test Strip to blood sample too long after the Meter begins testing may cause inaccurate results.

Note: If Meter does not show dashes in the Display soon after touching the sample to the Sample Tip, release and discard the Test Strip. Repeat the test with a new Test Strip and a new sample. If problem persists, see Troubleshooting,Section7.

8. Afterthetestisfinished,thebloodglucoseresultisdisplayed.

9. HoldtheTestStripvialwiththeTestStrippointingdown.PresstheStripReleaseButtontoreleaseanddiscardtheTestStripintotheappropriatecontainer.TheMeterturnsoff.

10.Recordtheresultasrequiredbyyourfacility.

System Out of Range Warning Messages

WARNING!

TheTRUE2goSystemaccuratelyreadsbloodglucoselevelsfrom20-600mg/dL.

Iftestresultislessthan20mg/dL,“Lo”appearsintheMeterDisplay.

Ifthetestresultisgreaterthan600mg/dL,“HI”appearsintheMeterDisplay.

ALWAYSrepeatthetesttoconfirmlow(“Lo”)orhigh(“HI”)results.Ifresultsstilldisplay“Lo”or“HI”,contacttheDoctororDiabetesHealthcareProfessionalimmediately.


Section 5:

Memory


Memory

Note: Use of the Memory feature may not be suitable for multi-patient use of the System. Check with the facility procedure/policy before use.

TheTRUE2goMeter’sMemoryholds99results.

TheoldestglucoseresultisremovedfromtheMemorywhentheMemoryisfullandanewglucoseresultisadded.

Viewing Memory

1. PresstheSetButtonforafewsecondsandrelease.TheMeterturnsonandthemostrecentresultinMemoryisdisplayed.

2. PresstheSetButtonandreleasetoadvancetothenextresultinMemory.ContinuetopressandreleasetheSetButtontoscrollthroughtheresults.HoldingtheSetButtonscrollsthroughtheresultsquickly.

Bloodtestresultsbeginas“R1”followedbytheglucoseresult.“R2”followswiththenextglucoseresult,andsoon.(R3,result;R4,result;…).

Controltestresultsbeginas“C1”followedbytheControlTestresult.“C2”followswiththenextControlTestresult,andsoon.(C3,result;C4,result;…).

Alternatesitebloodtestresultsbeginas“A1”followedbytheglucoseresult.“A2”followswiththenextglucoseresult,andsoon.(A3,result;A4,result;…).


34

BloodTestResult

ControlTestResult

AlternateSiteBloodTestResult


Section 6:

Care, Cleaning/Disinfection and Storage of System


CAUTION!Point-of-care blood testing devices such as blood glucose meters should be used only on one patient and not shared. If dedicating blood glucose meters to a single patient is not possible, the meters must be properly cleaned and disinfected after every use following the guidelines found in Meter Care, Cleaning/Disinfection.

CAUTION!Healthcare Professionals should wear gloves when cleaning anddisinfecting the Meter. Wash hands after taking off gloves as contactwith blood presents a risk of infection.

We recommend one meter per patient. We suggest cleaning and disinfection of Meter between patients when Meter is used on multiple patients.

Caring for the TRUE2go System

• StoretheSystem(Meter,TestStrips,GlucoseControlSolution)inan areaprotectedfromliquids,dustanddirt.• StoretheSysteminadryplaceatroomtemperature,36°-86°F. DO NOT REFRIGERATE OR FREEZE.

Meter Care, Cleaning/Disinfection

Note: Clean to remove blood or soil from the surface of your Meter and disinfect to destroy infectious agents on the surface of Meter after each use.

Remove meter from vial before cleaning to prevent deterioration of vial label.

• TocleananddisinfectMeter,usePDISuperSani-ClothGermicidal Disposablewipes(activeingredients-55%Isopropyl alcohol/Isopropanol,5,000ppm(PartsPerMillion)quarternary ammoniumchlorides)Viraguard/Viraholdwipes(activeingredient- 70%Isopropylalcohol/Isopropanol)ordisinfectantswithidentical activeingredientsfromwww.epa.gov/oppad001/list_d_hepatitisbhiv.pdf. Pleasefollowthepreparedwipesproductlabelmanufacturer’s instructionsforcleaninganddisinfectingtheMeter.• NeverputMeterinLiquidsorallowanyliquidstoentertheTestPorts.• LetMeterairdrythoroughlybeforetesting.• Pleasedisposeofwipesaftercleaning/disinfection.• Washhandsaftertakingoffgloves.• Useanewpairofglovesbeforetestingeachpatient.

Note: Prepared Isopropyl Alcohol (70%) wipes are commercially available from a variety of manufacturers. For more details on cleaning, contact our Customer Care using the phone number on the cover of the QA/QC Manual. For more information on the PDI Super Sani-Cloth wipes, visit www.pdipdi.com or for information on Viraguard wipes, visit www.veridien.com.


36


TRUEtest Test Strips

• StoreTestStripsinoriginalvialonly.DonottransferoldTestStrips intonewvialorstoreTestStripsoutsideofvial.• WritethedatefirstopenedonTestStripviallabel.Discardvialand unusedTestStripsifeitherEXP dateprintedonTestStripviallabel or4monthsafterdatewrittenonviallabelhaspassed.• CloseTestStripvialimmediatelyafterremovingoneTestStrip.Store inadryplaceatroomtemperaturebelow86°F. DO NOT REFRIGERATE OR FREEZE.• DonotreuseTestStrips.• Donotbend,cutoralterTestStripsinanyway.

TRUEtest Glucose Control Solution

• WritethedatefirstopenedonControlbottlelabel.Discardbottleif eitherEXP dateprintedonbottlelabelor3monthsafterdatewritten onbottlelabelhaspassed.• Afteruse,wipebottletipcleanandrecaptightly.• Storeatroomtemperature,36°-86°F. DO NOT REFRIGERATE OR FREEZE.


37


(Continued from previous page.)

Battery Replacement

If“Lb”or“db”appearsintheDisplay,changethebattery.Useonlyanew3Vnon-rechargeablelithiumbattery(#CR2032).

1. RemoveMeterfromvial(seeAttach/RemoveTRUE2goMetertoTRUEtestTestStripVial,Section2).

2. TurnMeterovertoseetheMeterlabelandBatteryCover.

3. PlacetheedgeofacoinintotheslotlocatedinthecenteroftheBatteryCover.TwistcoinslightlycounterclockwiseuntilBatteryCoverisloose.Removecoinfromslot.

4. HoldingtheMeteroveryourotherhand,turntheMeteroversotheMeterDisplayfacesup.TheBatteryCoverandbatterydropout.

5. TurnMeterbackover.Replacebatterywithanew3Vnon-rechargeablelithiumbattery(#CR2032),positive(“+”)sidefacingup.

6. ReplaceBatteryCover,withslotfacingupandmetaltipsinslots.FirmlypushBatteryCoverdownusingtheedgeofthecoinandturnthecoinslightlyclockwisetoclose.

7. Discardtheoldbatteryinanappropriatecontainer.

8. PresstheSetButtontoturntheMeteron.IfMeterwillnotturnon,checkthatthebatterywasinstalledproperlywith“+”facingup.Ifnot,removeandreinsertbatteryandtryagain.Callforassistanceifproblempersists.

9. OnceMeterturnson,re-attachMetertovial(seeAttach/RemoveTRUE2goMetertoTRUEtestTestStripVial,Section2).

Caution! Batteries may explode if mishandled or incorrectly replaced. Do not dispose of battery in fire. Do not take apart or attempt to recharge battery. Dispose according to local/country regulations.


38

Slot


Section 7:

Troubleshooting


Troubleshooting

ThefollowingisabriefguideforTroubleshootingthemostcommonerrorswhenusingTRUE2go.IfanyproblemsarisethatcannotberesolvedbyusingthisguideortheDisplayMessages,pleasecallforassistance.

1) After inserting Test Strip into Test Port, Meter does not turn on.

TestStripisinsertedupsidedownorbackwards.

- Remove Test Strip. Re-insert Test Strip correctly.

Stripnotfullyinserted.

-Remove Test Strip. Re-insert Test Strip fully into Meter.

Striperror.

-Remove Test Strip. Repeat with new Test Strip.

Deadornobattery.

-Replace battery.

Batteryinbackwards.

-Check placement of battery. Battery positive (“+”) side must face up.

Metererror.

-Call for assistance.

2) After applying the sample to the Test Strip, test does not start / Meter does not begin testing.

Sampletoosmall.

-Repeat test with a new Test Strip and a larger sample drop.

Sampleappliedaftertwominuteautomaticshut-offofMeter.

-Repeat test with a new Test Strip and apply sample within 2 minutes.

ProblemwithTestStrip.

-Repeat test with a new Test Strip.

ProblemwithMeter.

-Call for assistance.


40


Display Messages

Display Reason Action

Temperature ErrorToo cold or too hot for testing.

MoveSystemtoareabetween50°-104°Fandwait30minutesforSystemtoreachroomtemperaturebeforetesting.

Sample not detected or using wrong Test Strip

RetestwithanewTRUEtestTestStripandalargersample.

Used Test Strip, Test Strip outside of vial too long, sample on top of Test Strip

RepeatwithanewTestStrip.MakesuresampleistouchedtoedgeofSampleTip.Iferrorpersists,callforassistance.

Meter error Callforassistance.

Test Strip error RetestwithanewTestStrip.Iferrorpersists,callforassistance.

Test Strip removed during test

RetestwithanewTestStrip.MakesureresultisdisplayedbeforeremovingTestStrip.

Meter Error ResultwasnotrecordedinMemory.Retestwithanewstrip.Iferrorpersists,callforassistance.

Low Battery About50testscanbeperformedbeforebatterydies.Replacebattery.

Dead battery Replacebattery.

Out of range high results > 600 mg/dL

WARNING!

RetestwithanewTestStrip.Ifresultisstill“HI”or“Lo”,contactDoctorimmediately.

WARNING!

Out of range low results < 20 mg/dL

If error message still appears after action, any other error messages appear that are not shown above, or troubleshooting does not solve the problem, call for assistance.


41


Section 8:

Training CertificationProgram


TRUE2go Blood Glucose System Training Certification Program

Trainedandcompetenttestingpersonnelareessentialtogoodqualitytestingandpatientcare.Waivedtestingsitesaresubjecttoahighrateofpersonnelturnover.Personnelshouldbetrainedandcompetentineachtesttheywillperformbeforereportingpatientresults.Inaddition,trainingshouldincludeaspectsofsafety(includingInfectionControlPolicies)andQualityControl.TheRiskManagementandChiefMedicalOfficer,andotherpersonsresponsibleforoverseeingtestingshouldensurethattestingpersonnelreceiveadequatetrainingandarecompetenttoperformtheproceduresforwhichtheyareresponsible.9

Certificate Information

NiproDiagnostics,Inc.providesatrainingcertificatefortheuseoftheTRUE2goBloodGlucoseMonitoringSystemforpoint-of-caremulti-patientfacilities.TheTrainingCertificateprovidesarecordthatthepersonlistedontheCertificatehasbeentrainedcorrectlyintheuseoftheTRUE2goSystemandunderstandsallproceduresandlimitationsconcerningtheTRUE2goSystem.

A.CertifiedTrainer

CertifiedTrainersarepersonnelfromthefacilitywhohavereceivedaTrainer’sCertificatefromNiproDiagnostics,Inc.ToobtainaTrainer’sCertificate,thepersonmust:

1.WatchandunderstandtheTRUE2goClinicalTrainingVideo(ifavailable). 2.ReadandbefamiliarwiththeentireQualityAssurance/QualityControlManualandallproduct

InstructionsforUse(TestStrip,GlucoseControlSolution,Owner’sBooklet). 3.CompletetheTrainingChecklistandPostTestincludedinthisManual. 4.SubmitcompletedPostTestto: LTCTrainingCertification Attn.:CustomerCareManager 2400NW55thCt. FortLauderdale,FL33309

NiproDiagnostics,Inc.willreturnaTrainer’sCertificateuponsatisfactorycompletionofthePostTest(100%scorerequired).UponreceivingtheTrainer’sCertificatefromNiproDiagnostics,Inc.,CertifiedTrainersarequalifiedtotrainappropriatepersonnelattheirfacilitytobeApprovedTesters.TrainingChecklistsandCertificatesmustbefiledintheemployee’sfileatthefacility.

• RISKMANAGEMENTANDCHIEFMEDICALOFFICERMUSTBECERTIFIEDACCORDING TO THIS TRAINING CERTIFICATION PROGRAM.

• CERTIFIEDTRAINERSMUSTBERE-CERTIFIEDEVERY12MONTHS.

Nipro Diagnostics will make every effort to contact your facility to inform you of expired training certificate and the need to complete the re-certification process.


43


B.ApprovedTesters

ApprovedTestersmustbetrainedbyCertifiedTrainersbeforetheyperformControlTestsorbloodglucosetestingusingtheTRUE2goSystem.TobecomeanApprovedTester:

1.WatchtheTRUE2goClinicalTrainingVideo(ifavailable). 2.SuccessfullycompletetheTrainingChecklistundertheinstructionofaCertifiedTrainer. 3.DemonstratethepropertechniquefortestingwiththeTRUE2goSystemusingtheappropriate

bloodandControlsamples. 4.Identifythefacility’sQualityControlPolicyandProcedures,includingdocumentationofQuality

Control.

Upontheperson’ssatisfactorycompletionoftheabove,theCertifiedTrainerdocumentsthetraining,signstheTrainingChecklistandfilesthecompletedChecklistintheemployee’sfileatthefacility.

APPROVED TESTERS MUST BE RE-TRAINED EVERY 12 MONTHS BY A CERTIFIED TRAINER.


44



45

TRUE2go® Blood Glucose System Training Checklist (Pleaseprint)

Name _______________________________________________________ Date _____/_____/_____

Title _____________________________________________________________________________

Facility __________________________________________________________________________

Confirmed by Certified Trainer (printnameandsign) ____________________________________

1.TheTesterhascompletedthefollowing:

____ViewedtheClinicalTrainingVideo(ifavailable) ____ReadtheOwner’sBooklet ____ReadtheTestStripInstructionsforUse(Insert) ____ReadtheGlucoseControlInstructionsforUse(Insert) ____ReadtheQA/QCManual

2. TheTesterunderstandsthefollowing:

____UseoftheTRUE2goSysteminaclinicalsetting ____CLIAregulationsforpoint-of-carebloodglucosetesting ____Systemspecifications ____Limitationsandcriticalsafetyinformation,includingthattheTRUE2goSystemmustnotbe

usedforcertainpatients(newborns,peritonealdialysispatients,etc.)

3.FamiliarizationwiththecomponentsoftheSystem.

a.Meter

____LocationofserialnumberfortheMeter ____Locationofphonenumberforassistance ____ReviewofMeterbuttonsandfunctions

b.TestStrips

____Identifieslotnumber ____WritesopendateonTestStripviallabel ____UnderstandstheExpirationDates,bothprintedandwritten ____ReviewsproperhandlingofTestStripsincludingrecappingoftheStripvialimmediately

afterremovingTestStrip ____DemonstratesproperinsertionoftheTestStripintotheMeter

c.GlucoseControlSolution

____Identifieslotnumber ____WritesopendateonControlbottlelabel ____UnderstandstheExpirationDates,bothprintedandwritten ____IdentifiesControllevel ____IdentifiesControlranges


TRUE2go® Blood Glucose System Training Checklist (Pleaseprint)

Name _______________________________________________________

4. QualityControlTests

____Understandsmanufacturer’sinstructionsforcontroltesting ____Understandsthepurposeoftheautomaticself-checkoftheMeteruponinsertionofTestStrip

intoTestPort ____UnderstandsthepurposeofControlTests,thefrequencyoftesting,andthenumberof

Controllevelstobetested ____Understandsthetestingtemperaturerangeandwhatmayresultiftestingtemperatureisoutof

range ____Identifiescorrect(unopenedvs.opened)ExpirationDatesontheControlbottle ____IdentifiesthecorrectControlrangefortheControllevelandunderstandsthetroubleshooting

iftheControlTestresultisnotwithintheacceptablerange ____DemonstratestheprocedureusingtheGlucoseControlSolution ____RecordstheControlTestresultontheTRUE2goQualityControlLog

5. BloodCollection

____Understandsthepropertechniqueofcapillarybloodcollectionforbothfingerandforearmsamples

____Understandswhenfingershouldbeusedinsteadofforearm ____Demonstratestheabilitytoobtainasufficientamountofbloodfortestingfrombothafinger

tipandforearm ____Understandsfacility’sprocedureonobtainingvenousbloodsamplesandthecorrecttubestouse

6. DemonstrationofBloodGlucoseTesting

____DemonstratesproperbloodglucosetestingprocedurefortheTRUE2goSystem ____UnderstandstheproperbloodapplicationtotheSampleTipandthesignificanceofthe

symbolsintheDisplay

7. PatientBloodGlucoseTestResults

____Demonstratestheproperdocumentationoftestresults ____Understandsthetroubleshootingiftestresultsarenotwithinthepatienttargetrange(e.g.,

performQualityControlTests,repeattest,possibletherapychangeafterconsultationwithDoctororDiabetesHealthcareProfessional,etc.)

____UnderstandsthatuseofMemoryfeaturemaynotbeappropriateformulti-patientfacilities. ____Properdisposalofbiohazardousmaterialsperfacilitypolicyandprocedures

8. Care,Cleaning/DisinfectionandStorageofSystem

____Understandsanycleaning/disinfectingproceduresforInfectionControl ____Demonstratesbatteryreplacement ____UnderstandsproperstorageofMeter,TestStrips,andGlucoseControlSolution


46


TRUE2go® Blood Glucose System Certified Trainer Post Test (Pleaseprint)

Name _______________________________________________________ Date _____/_____/_____

Title _________________________________________Facility _____________________________

DoesthefacilitycorrespondingtothisTrainingCertificationprovideanyofthefollowingpatientservices? __________Yes __________No

- Peritonealdialysiswithsolutionscontainingicodextrin(e.g.Extraneal,Icodial)thatismetabolizedtomaltose,

- Injectionsorinfusionsofsolutionscontaininggalactoseormaltose,includingsomehumanimmunoglobulinpreparations(e.g.Octagam),

- Xyloseabsorptiontesting,- Intervenoussolutionscontainingmaltoseasasubstituteforglucoseorasameansforpatient

hydration,- Drugs,includinginvestigationaldrugsandthosemadebycompoundingpharmacies,which

containormetabolizemaltose,galactose,orxylose.

Address __________________________________________________________________________

Phone/Fax________________________________________________________________________

E-mail Address* ___________________________________________________________________*Forproductupdatesandrecertificationnotices.Notforpromotionalpurposes.

True or False

1.AllHealthcareProfessionalsperformingbloodglucosemonitoringusingtheTRUE2goSystemshouldcompletethetrainingprogram.

__________True __________False

2.TheTRUE2goSystemcanbeusedonnewborns.

__________True __________False

3.Apatientreceivingperitonealdialysiswithicodextrin(ExtranealorIcodial)orsolutionscontainingmaltoseormetabolizingtomaltose,orgalactose(suchasOctagam)canbetestedusingtheTRUE2goSystem.

__________True __________False

4.TheTRUE2goMetermaybeusedwithoutattachmenttotheTestStripvial.

__________True __________False


47



48


Name _______________________________________________________

5.QualityControlTestingshouldbeperformedperyourfacility’spoliciesandprocedures.

__________True __________False

6.AnycontrolsolutioncanbeusedwiththeTRUE2goSystem.

__________True __________False

7.Criticallyillpatients(shock,hyperglycemic-hyperosmolarstate,withorwithoutketosis)shouldbe testedwiththeTRUE2goSystem.

__________True __________False

8.IftheMeterbecomessoiled,wipeitoffwithIsopropylalcohol(70%)wipes,PDISuperSani-clothwipesorViraguardwipes.

__________True __________False

9.ThebatteryshouldbereplacedwithanAAAalkalinebattery.

__________True __________False

Multiple Choice (choose only one answer for each question)

1.TrainingontheuseoftheTRUE2goSystemconsistsofreviewingthefollowing:

a)TheClinicalTrainingVideo(ifavailable) b)TheQA/QCManual c)TheOwner’sBooklet d)TestStripInstructionsforUse e)ControlSolutionInstructionsforUse f)Alloftheabove

2.Ifapoint-of-carebloodglucosetestisorderedonapatient,thetestermust:

a)Identifytreatment(s)patientmaybeonorstarting b)Identifydrugtherapy(ies)patientmaybeonorstarting c)Identifyanduseappropriatepoint-of-carebloodglucosetestingsystem d)Alloftheabove



49


Name _______________________________________________________

3.TheTRUE2goSystemutilizesthefollowingenzymetotestforglucose:

a)Glucoseoxidase(GO) b)GDH-PQQ c)GDH-NAD d)GEH-PDQ

4.TheTRUE2goSystemmustnotbeusedforthefollowingpatientconditions:

a)Peritonealdialysispatientsreceivingdialysissolutionscontainingicodextrin(e.g. Extraneal®,Icodial®)thatismetabolizedtomaltoseb)Injectionorinfusionofsolutionscontaininggalactoseormaltose,includingsome humanimmunoglobulinpreparations(e.g.Octagam®)c) Patientsundergoingxyloseabsorptiontestingd)Patientsreceivingintravenoussolutionscontainingmaltoseasasubstituteforglucoseoras ameansforpatienthydratione)Anydrugs,includinganyinvestigationaldrugsandthosemadebycompoundingpharmacies. whichcontainormetabolizetomaltose,galactose,orxylosef) Alloftheabove

5.UsingtheTRUE2goSystemontheabovepatientsmaycause:

a)Falselowglucoseresults b)Metertomalfunction c)Falsehighglucoseresults d)Controlsolutiontoreadasblood e)Inappropriatetreatmentthatmayresultindeath f)aandd g)cande h)bande

6.Thefollowingsample(s)is/areappropriatefortestingontheTRUE2goSystem:

a)Capillarywholebloodfromfingertiporforearm b)Venouswholebloodcollectedinaredtoptube c)Plasma d)Urine e)Venouswholebloodcollectedinapurpletoporgreentoptube f)aandc g)bandd h)aande



50


Name _______________________________________________________

7.Thephonenumberforassistanceislocated:

a)OntheOwner’sBookletcover b)OnthecoveroftheQA/QCManual c)OnthebackMeterlabel d)OntheTestStripInstructionsforUse e)Alloftheabove

8.ThefollowingtestsareusedforQualityControloftheTRUE2go:

a)OnelevelofGlucoseControlandapatientsample b)OnelevelofGlucoseControl c)AlowlevelofGlucoseControlandahighlevelofGlucoseControl d)Meterautomaticself-testandaminimumof2levelsofGlucoseControl

9.TheGlucoseControlopenbottleexpirationdateis:

a)Oneweekafteropening b)120daysafteropening c)3monthsafteropening d)Thedatepre-printedonthebottle

10.IftheControlTestresultisoutofrange,itmaybebecause:

a)TheControlhasexpired b)TheTestStriphasexpiredorthevialwasnotclosed c)ThecapwasleftofftheControlbottle d)TheopendatewrittenontheControlbottleorTestStripvialhaspassed e)Alloftheabove

11.Forearmtestingmaynotbeappropriateinthefollowingsituations:

a)Within2hoursofexercise b)Ifthepatient’sglucoseresultoftenfluctuates c)Ifthepatientisunderstress d)Alloftheabove

12.TRUEtestTestStripsopenvialexpirationdateis:

a)18months b)12months c)6months d)4months


13.Retrainingofallpersonnelmustbeperformedwithin

a)6months b)12months c)8months d)30days

14.IfafterinsertingtheTestStripintotheTestPort,theMeterdoesnotturnon,thereasoncouldbe

a)TheTestStripwasinsertedupsidedown b)TheTestStripwasnotfullyinserted c)Thebatteryisdead d)Alloftheabove

For Nipro Diagnostics, Inc. Use Only

Score _______________________________________________________

Reviewed by _________________________________________________ Date _____/_____/_____ Printname

____________________________________________________________ Signname

CertificateIssued: ____________Yes____________NoDate _____/_____/_____


51



52


Section 9:

Forms


54

QU

ALI

TY C

ON

TRO

L R

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RD

Met

er S

eria

l Num

ber _

____

____

____

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any

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- Le

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l ___

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be

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be

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used

.


55

QU

ALI

TY C

ON

TRO

L R

ECO

RD

Met

er S

eria

l Num

ber _

____

____

____

____

(7-d

igit

num

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nM

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labe

lbelow

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ote

any

prob

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s in

Trou

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belo

w.

Test

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ips

Glu

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- Le

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____

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At-Risk Patient Identification Notice(For patient bedside, with patient chart and in applicable treatment areas)

WARNING!Do not use TRUE2go System

for Blood Glucose Testing!_______ Patient on peritoneal dialysis

_______ Patient receiving solutions containing galactose or maltose, including some human immunoglobulin preparations

_______ Patient undergoing xylose absorption testing

_______ Patient receiving IV solution containing maltose

_______ Patient receiving drug therapies that contain or metabolize to maltose, galactose, or xylose

WARNING!


56


Section 10:

TRUE2go® Lifetime Warranty


TRUE2go Limited Lifetime Warranty

NiproDiagnostics,Inc.providesthefollowingWarrantytotheoriginalpurchaseroftheTRUE2goBloodGlucoseMeter:

1)NiproDiagnostics,IncwarrantsthisMetertobefreeofdefectsinmaterialsandworkmanshipatthetimeofpurchase.IftheMeteriseverinoperative,NiproDiagnostics,Inc.willreplacetheMeterwithanequivalentMeter,atitsoption,atnocosttothepurchaser.FailureoftheMeterduetoabuseorusenotinaccordancewiththeinstructionsforuseisnotcoveredbythisWarranty.

2)ThisWarrantydoesnotincludethebatterysuppliedwiththeMeter.3)DonottaketheMeterapart.ThisactionwillvoidtheWarrantyandcausethe

Metertodisplayfalseresults.4)ThedurationofanyimpliedWarranty,includinganyimpliedWarrantyof

merchantabilityorfitnessforaparticularpurposeshallbelimitedtothelifetimeinusewiththeoriginaluserinaccordancewithanystatelawtothecontrary.

5)NiproDiagnostics,Inc.disclaimsliabilityforincidentalorconsequentialdamagesforbreachofanyexpressedorimpliedWarranty,includinganyimpliedWarrantyofmerchantabilityorfitnessforaparticularusewithrespecttotheMeter.Somestatesdonotallowtheexclusionorlimitationofincidentalorconsequentialdamages,sotheabovelimitationsorexclusionmaynotapply.

6)ThisWarrantygivestheuserspecificlegalrights,andtheusermayalsohaveotherrightswhichvarystatetostate.

YourNiproDiagnostics,Inc.CustomerCareRepresentativewillbeabletoprovidedetailedinformationregardingproceduresforreturningyourMeter,ifnecessary.


58


Section 11:

References


References

1. FDAPublicHealthNotification:Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Blood Borne Pathogens: Initial Communication (2010)http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices.

2. CDCClinicalReminder:Use of Fingerstick Devices on More than one Person Poses Risk for Transmitting Bloodborne Pathogens (2010)http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html.

3. U.S.FoodandDrugAdministration,CenterforBiologicsEvaluationandResearch.Important Safety Information on Interference With Blood Glucose Measurement Following Use of Parenteral Maltose/ParenteralGalactose/Oral Xylose - Containing Products.[ElectronicVersion].RetrievedJune30,2009.www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm154213.htm.

4. U.S.FoodandDrugAdministration.Blood Glucose Meters - Getting the Most Out of Your Meter.[ElectronicVersion].RetrievedJune16,2009:www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm109371.htm.

5. Dataonfile.

6. Larsson-CohnU:Difference between capillary and venous blood glucose during oral glucose tolerance tests.ScandJClinLabInvest36:805-808,1976.

7. Atkins,S.H.,Dasmahapatra,A.,Jaker,M.A.,Chorost,M.I.,Redd,S.,Fingerstick Glucose Determination in Shock.AnnalsofInternalMedicine,114:1020-1024,1991.

8. JoslinDiabetesCenter.GoalsforBloodGlucoseControl[ElectronicVersion].RetrievedSeptember28,2010.fromwww.joslin.org/info/goals_for_blood_glucose_control.htm.

9. Good Laboratory Practices for Waived Testing Sites.[ElectronicVersion].RetrievedJuly14,2008:www.cdc.gov/mmwr/preview/mmwrhtml/rr5413a1.htm.


60F9NPD21Rev.22


attention - trividia health · attention: risk management and ... • quality control program...

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