BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 1760950 · Received July 17, 2007

    Report

    Report Number
    1823260-2007-06188
    Event Type
    Malfunction
    Date Received
    July 17, 2007
    Date of Event
    June 19, 2007
    Report Date
    July 17, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K930979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    WHILE ON THE LINE WITH TECHNICAL SUPPORT, PATIENT PERFORMED A DISPLAY TEST AND FOUND THAT SEGMENTS WERE MISSING FROM THE ADVANTAGE METER'S RESULT DISPLAY. ADDITIONALLY, PATIENT INDICATED THAT NO ICONS APPEARED DURING THE DISPLAY TEST. NO ADVERSE EVENT WAS REPORTED. TECHNICAL SUPPORT REQUESTED THE RETURN OF THE SUSPECT PRODUCT AND REPLACEMENT PRODUCT WAS SHIPPED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR NIASPAN 1000 MG - ONCE DAILY, 3 YEARS| LOSARTAN 100 MG - ONCE DAILY, 3 YEARS| SYNTHROID 0.112 MG - ONCE DAILY, 4 YEARS| HYDRALAZINE 50 MG - THREE TIMES DAILY, 1 YEAR| BENAZEPRIL 20 MG - ONCE DAILY, 1 YEAR| CALCITRIOL 0.25 MG - ONCE DAILY, 3 MONTHS| ALLOPURINOL 100 MG - ONCE DAILY, 4 YEARS| OMEPRAZOLE 20 MG - ONCE DAILY, 3 YEARS| DIGOXIN 0.125 MG - ONCE DAILY, 6 YEARS| LASIX 80 MG AM, 40 MG PM - 6 YEARS| ZETIA 10 MG - ONCE DAILY, 3 YEARS| LIPITOR 80 MG - ONCE DAILY, 3 YEARS| SOTALOL 160 MG - TWICE DAILY, 1.5 YEARS| METOPROLOL 100 MG - 3 YEARS| REPAGLINIDE 0.5 MG - WITH MEALS, 3 YEARS| COUMADIN 8.5MG - ONCE DAILY, 2 YEARS