BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1200138 · Received October 15, 2008

    Report

    Report Number
    1823260-2008-07641
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR THE SUSPECT DEVICE USED IN ADVANTAGE SYSTEM #2. PLEASE SEE MEDWATCH FOR SUSPECT DEVICE IN ADVANTAGE SYSTEM #1.

    Description of Event or Problem · 1

    CALLER REPORTS BACK TO BACK RESULTS OF 32 MG/DL ON ADVANTAGE SYSTEM #1 COMPARED TO RESULTS OF 78MG/DL OR 79MG/DL ON ADVANTAGE SYSTEM #2. CALLER REPORTS QUALITY CONTROLS WERE RUN WEEKLY AND IN RANGE. 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 550079

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR