BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1082799 · Received July 24, 2008

    Report

    Report Number
    1826988-2008-00803
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 30, 2008
    Report Date
    June 30, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HIS CONTOUR METER. WHILE TROUBLESHOOTING, HE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 273 MG/DL. THE NORMAL CONTROL RANGE WAS 98-136 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER DID NOT HAVE ANY TEST STRIPS LEFT AFTER TROUBLESHOOTING, SO NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 7151B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK