BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ADVANTAGE METER

    MDR report key: 1760983 · Received July 17, 2007

    Report

    Report Number
    1823260-2007-06179
    Event Type
    Malfunction
    Date Received
    July 17, 2007
    Date of Event
    June 29, 2007
    Report Date
    July 17, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K032552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS OBTAINING A BLOOD GLUCOSE RESULT OF 640 MG/DL ON THE ADVANTAGE SYSTEM. THE DEVICE'S NUMERIC READING RANGE IS 10-600 MG/DL; VALUES >600 MG/DL SHOULD DISPLAY AS "HI." CUSTOMER WAS ALSO TESTED ON DOCTOR'S METER WITH A RESULT OF 500 MG/DL. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ADVANTAGE METER BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR GLUCOVANCE - 5/500MG, TWICE A DAY, 3 YEARS| ACOR - 30MG, ONCE A DAY, 6 MONTHS