BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (10)

    MDR report key: 1163650 · Received September 9, 2008

    Report

    Report Number
    1826988-2008-01003
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HER CONTOUR METER. WHILE TROUBLESHOOTING, SHE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 175 MG/DL. THE NORMAL CONTROL RANGE WAS 99-133 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER IS TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS (10) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 9507B 6HC3B51

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK