BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1041192 · Received May 9, 2008

    Report

    Report Number
    1823260-2008-03881
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    May 3, 2008
    Report Date
    May 9, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT SHE OBTAINED THE BLOOD GLUCOSE COMPARISON OF 217 MG/DL AND 99 MG/DL ON THE ACCU-CHEK AVIVA SYSTEM. THE RESULTS WERE OBTAINED WITHIN A 10 MINUTE TIMEFRAME. THE REPORTER FELT HYPOGLYCEMIC. NO REPORTED ACTONS TAKEN OR TREATMENT RENDERED. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    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 300914

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR GLIPIZIDE 15MG/DAY - 2.5 YEARS