BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHECK COMFORT CURVE TEST STRIPS

    MDR report key: 1001777 · Received February 19, 2008

    Report

    Report Number
    1823260-2008-01675
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 330 MG/DL AND 71 MG/DL, 71 MG/DL AND 376 MG/DL, 376 MG/DL AND 87 MG/DL. QUALITY CONTROLS WERE EXPIRED. 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-CHECK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING DEVICE - LFR LFR ROCHE DIAGNOSTICS 549642

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NOVOLIN 70/30 65 UNITS 2X/DAY 20 YRS| "R" AS NEEDED