BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1191882 · Received October 1, 2008

    Report

    Report Number
    1823260-2008-07290
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 1, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THE USE BY DATE ON THE COMFORT CURVE TEST STRIP VIAL LABEL IS 04/2007; MFR'S BATCH RECORD CONFIRMED THE ACTUAL USE BY DATE TO BE 04/30/2005. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF PROD, 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 546832

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK METFORMIN