BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1080517 · Received July 22, 2008

    Report

    Report Number
    1823260-2008-05628
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 12, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 123 MG/DL BACK TO BACK WITH A RESULT OF 60 MG/DL ON THE AVIVA SYSTEM WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS-LFR LFR ROCHE DIAGNOSTICS 301029

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR JANUVIA 6 MONTHS 100 MG DAILY| REQUIP 1 MG 3 TIMES DAILY| GLYBURIDE/METFORMIN 10/100 MG TWICE DAILY| LIPITOR 20 YEARS 20 MG DAILY| FUROSEMIDE 40 MG DAILY| PREVACID 5-10 YEARS - 30 MG DAILY| LEXAPRO - 5 YEARS - 30 MG DAILY| METOPROLOL 150 MG TWICE DAILY| SINEMET -50/200 MG 3 TIMES DAILY| DESYREL - 20 YEARS 300 MG DAILY