BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR TS

    MDR report key: 1163655 · Received September 9, 2008

    Report

    Report Number
    1826988-2008-01008
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 20, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE CALLED FOR HELP WITH THE CUSTOMER'S METER. WHILE TROUBLESHOOTING, HE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 193 MG/DL. THE NORMAL CONTROL RANGE WAS 103-142 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE ADVOCATE USED THE REMAINING TEST STRIPS WHILE TROUBLESHOOTING, SO NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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