BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1111923 · Received August 8, 2008

    Report

    Report Number
    1826988-2008-00854
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 14, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 238 MG/DL. THE NORMAL CONTROL RANGE WAS 101-140 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED 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 (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 7080D 7LC3D15

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK