BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1761230 · Received July 23, 2007

    Report

    Report Number
    1823260-2007-06418
    Event Type
    Malfunction
    Date Received
    July 23, 2007
    Date of Event
    July 6, 2007
    Report Date
    July 23, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE ADVANTAGE SYSTEM WITH RESULTS OF 164 MG/DL AND 240 MG/DL. NO QUALITY CONTROLS WERE RUN. NO ADVERSE EVENT REPORTED. CUSTOMER HAD NO STRIPS TO RETURN SO A REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING DEVICE - LFR LFR ROCHE DIAGNOSTICS 549556

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR OTHER MEDICATION UNK| HUMILIN N 52 UNITS 3XDAY| HUMILIN R 4 UNITS 3XDAY - SLIDING SCALE