BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1771139 · Received February 5, 2008

    Report

    Report Number
    1823260-2008-01241
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    December 7, 2007
    Report Date
    February 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS BACK TO BACK TESTING TO A PROFESSIONAL METER WHILE USING THE ADVANTAGE SYSTEM WITH RESULTS BETWEEN 165 - 200'S MG/DL ON CUSTOMER'S METER AND 135 MG/DL ON PROFESSIONAL METER. NO QUALITY CONTROLS WERE RUN DURING THE CALL. NO ADVERSE EVENT REPORTED. 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 COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR METFORMIN, 1000 MG/2X DAY - 14 MONTHS| GLIPIZIDE, 10 MG/DAY - 14 MONTHS