BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1070619 · Received July 1, 2008

    Report

    Report Number
    1826988-2008-00739
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    June 17, 2008
    Report Date
    June 17, 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 ADVOCATE CALLED FOR HELP WITH THE CUSTOMER'S CONTOUR METER. WHILE TROUBLESHOOTING, IT WAS DISCOVERED THE METER DISPLAY WAS MISSING SEGMENTS. THE CUSTOMER WAS NOT AWARE OF THE MISSING SEGMENTS, BUT NO ADVERSE EVENTS WERE ALLEGED. THE METER IS TO BE RETURNED FOR EVALUATION. A NEW CONTOUR METER KIT WAS 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 7151 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK