BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1212757 · Received October 20, 2008

    Report

    Report Number
    1826988-2008-01204
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 2, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 226 MG/DL. THE NORMAL CONTROL RANGE WAS NOT PROVIDED, BUT SHOULD BE AROUND 100-138 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVAL. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 7183 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK