BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1123932 · Received August 15, 2008

    Report

    Report Number
    1823260-2008-06256
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 188MG/DL, 301MG/DL, 372MG/DL, 479MG/DL AND 170MG/DL. L1 QUALITY CONTROL WAS RUN AND IN RANGE. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OR THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 550510

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR COZAAR| JANUVIA| METFORMIN| GLIPIZIDE