BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1770668 · Received October 30, 2007

    Report

    Report Number
    1823260-2007-09426
    Event Type
    Malfunction
    Date Received
    October 30, 2007
    Date of Event
    September 19, 2007
    Report Date
    October 30, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THERE IS NO USE BY DATE, NO LOT NUMBER OR ANY CONTROL RANGES STAMPED ON TEST STRIP VIAL WHILE USING THE ADVANTAGE SYSTEM. CUSTOMER REPORTS A CATALOG NUMBER THAT IS VERY OLD AND (B)(4) AGENT STATES THEY SHOULD BE EXPIRED. UNABLE TO VERIFY WITH BATCH RECORD DUE TO NO LOT NUMBER. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE 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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR HUMULIN 70/30 - 15 UNITS IN PM - 3 YEARS| HUMULIN 70/30 - 20 UNITS IN AM - 3 YRS