BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1279692 · Received December 23, 2008

    Report

    Report Number
    1823260-2008-09459
    Event Type
    Malfunction
    Date Received
    December 23, 2008
    Date of Event
    December 16, 2007
    Report Date
    December 23, 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 ALLEGED BLOOD GLUCOSE RESULTS OF 89-98MG/DL AND 89-98 MG/DL ON A PROFESSIONAL METER AND 190-199 MG/DL WHEN TESTING WAS PERFORMED BACK-TO-BACK ON THE ADVANTAGE SYSTEM. CUSTOMER REPORTED NO SYMPTOMS OR TREATMENT. THE SUSPECT DEVICE HAS BEEN DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION; 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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR GLYBURIDE - 4 YEARS