BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR TS

    MDR report key: 1120986 · Received August 13, 2008

    Report

    Report Number
    1826988-2008-00864
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 16, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HIS CONTOUR TS METER. WHILE SCROLLING THROUGH THE METER MEMORY, HE ALLEGED THAT HE RECEIVED A READING OF 778 MG/DL. THE CUSTOMER WAS TOLD THAT ANY READING OVER 600 MG/DL WOULD READ "HI". THE CUSTOMER CHECKED THE MEMORY AGAIN AND ALLEGED THAT THE A SEGMENT IN THE 100'S POSITION WAS FLASHING MAKING THE READING APPEAR TO BE 778 OR 178 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE METER WAS RETURNED FOR EVAL OF POSSIBLE MISSING OR EXTRA SEGMENTS. A REPLACEMENT METER WAS 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