BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR TS

    MDR report key: 1211918 · Received October 20, 2008

    Report

    Report Number
    1826988-2008-01208
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 6, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HIS CONTOUR TS METER. WHILE TROUBLESHOOTING, HE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 399 MG/DL. THE NORMAL CONTROL RANGE WAS 106-147 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS WERE TO BE RETURNED FOR EVALUATION, BUT THE CUSTOMER REFUSED TO SEND THEM BACK. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA CONTOUR TS BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 1801 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK