BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTODISC 50 TEST STRIPS

    MDR report key: 857020 · Received May 25, 2007

    Report

    Report Number
    1826988-2007-00274
    Event Type
    Malfunction
    Date Received
    May 25, 2007
    Date of Event
    May 16, 2007
    Report Date
    May 16, 2007
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HIS METER. WHILE TROUBLESHOOTING, HE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 551 MG/DL. THE NORMAL CONTROL RANGE WAS 113-163 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVAL, AND REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTODISC 50 TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW BAYER HEALTHCARE LLC 3623A 2A3140AA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR