BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 964473 · Received December 12, 2007

    Report

    Report Number
    1823260-2007-10680
    Event Type
    Malfunction
    Date Received
    December 12, 2007
    Date of Event
    November 17, 2007
    Report Date
    December 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 180, 130, 179, AND 90 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 5 MINS OF EACH OTHER ON THE ADVANTAGE SYSTEM. NO ACTIONS WERE REPORTED OR TREATMENT RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT PRODUCT 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 TEST STRIPS-LFR LFR ROCHE DIAGNOSTICS 550014

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR AMARYL