BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1052353 · Received May 6, 2008

    Report

    Report Number
    1823260-2008-03803
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 6, 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

    THE REPORTER STATES THAT HE OBTAINED THE BLOOD GLUCOSE COMPARISONS WITH RESULTS 380 MG/DL, 120 MG/DL, 143 MG/DL, 135 MG/DL, 146 MG/DL AND 183 MG/DL ON THE ACCU-CHEK AVIVA SYSTEM. THERE WERE SIX DIFFERENT BLOOD GLUCOSE COMPARISONS CONDUCTED AND THE RESULTS WERE OBTAINED WITHIN 10 MINUTE TIMEFRAMES. NO REPORTED ACTIONS 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 301089

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR GLIMEPIRIDE 1 MG/DAY - 4 MONTHS