BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1172501 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07006
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THE USE BY DATE ON THE COMFORT CURVE TEST STRIP VIAL LABEL IS 10/31/2008; MANUFACTURER'S BATCH RECORD CONFIRMED THE ACTUAL USE BY DATE TO BE 06/30/2008. THE STRIP VIAL IS ERRONEOUSLY LABELED, POSSIBLY ALLOWING CUSTOMER TO TEST BEYOND ACTUAL EXPIRATION DATE. NO ADVERSE EVENT REPORTED. BATCH RECORD EXPIRATION DATE CONFIRMATION ATTACHED. REQUESTED RETURN OF PRODUCT, REPLACEMENT 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 549644

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INSULIN 13 YEARS