BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1181958 · Received September 22, 2008

    Report

    Report Number
    1823260-2008-07080
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS STRIP LABEL EXPIRATION DATE IS 10/30/2003 WHILE USING COMFORT CURVE TEST STRIPS. BATCH RECORD VERIFICATION SHOWS EXPIRATION DATE IS 11/30/2003. CUSTOMER WAS USING EXPIRED STRIPS. NO QUALITY CONTROLS WERE RUN. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF 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 CORP. 546013

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK