BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1772048 · Received November 2, 2007

    Report

    Report Number
    1823260-2007-09536
    Event Type
    Malfunction
    Date Received
    November 2, 2007
    Date of Event
    October 8, 2007
    Report Date
    November 2, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS VIAL EXPIRATION DATE OF 08/28/2007 WHILE USING COMFORT CURVE TEST STRIPS. ACC AGENT REPORTS (B)(4) SHOWS EXPIRATION DATE OF 02/28/2007. EXPIRATION DATE VERIFIED THROUGH BATCH RECORDS AS 02/28/2007. 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 548738

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK