BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1781017 · Received July 26, 2007

    Report

    Report Number
    1823260-2007-06538
    Event Type
    Malfunction
    Date Received
    July 26, 2007
    Date of Event
    July 16, 2007
    Report Date
    July 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED BLOOD GLUCOSE RESULTS OF 299 MG/DL AND 100 MG/DL WHEN TESTING WAS PERFORMED WITHIN 6 MINUTES ON THE ADVANTAGE SYSTEM. CUSTOMER REPORTED HAVING NO SYMPTOMS AND DID NOT TREAT/ACT ON RESULTS. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND 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 549309

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR "RANADEN" - 7 YEARS - 150MG AS NEEDED| CLONAZEPAM - 10 YEARS - 2MG DAILY| ASPIRIN - 10 YEARS - 81MG DAILY| METFORMIN - 9 YEARS - 475MG THRICE DAILY| LEVOTHYROXINE - 7 YEARS - 2.5MG DAILY| SIMVASTATIN - 10 YEARS - 20MG DAILY