BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1766184 · Received October 16, 2007

    Report

    Report Number
    1823260-2007-09058
    Event Type
    Malfunction
    Date Received
    October 16, 2007
    Date of Event
    October 2, 2007
    Report Date
    October 16, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS USE BY DATE ON TEST STRIP VIAL IS 02/2008; MANUFACTURER'S DATABASE AND BATCH RECORD CONFIRMED THE ACTUAL USE BY DATE TO BE 05/31/2007. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 20656042

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR AVANDIA 500MG 7-8AM/4-5PM - 1 WEEK| MOTRIN 800MG AS NEEDED - 2 YEARS