BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 800086 · Received December 22, 2006

    Report

    Report Number
    1823260-2006-07701
    Event Type
    Malfunction
    Date Received
    December 22, 2006
    Date of Event
    November 16, 2006
    Report Date
    December 22, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    k010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE EXPIRATION DATE FOR, CAT # 2030381, LOT 545921 IS 09/30/03. THE CUSTOMER REPORTS THE EXPIRATION DATE ON THE STRIP VIAL IS 09/30/2007. THE ACTUAL EXPIRATION DATE IS 09/30/03. NO REPORT OF AN ADVERSE EVENT AND/OR SERIOUS INJURY. CONTROLS WERE NOT RUN. RETURN REQUESTED AND 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 * 545921

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR BACLOFEN - 13 YRS VARIES - PUMP IMPLANTED.| METFORMIN - 5 YRS 1000 MG 2X DAY