BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1071521 · Received July 3, 2008

    Report

    Report Number
    1826988-2008-00776
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER, A HEALTHCARE PROFESSIONAL, CALLED FOR HELP WITH ONE OF THE CONTOUR METERS THAT BELONGS TO HER FACILITY. WHILE TROUBLESHOOTING, IT WAS DISCOVERED THE METER DISPLAY WAS MISSING SEGMENTS. THE CUSTOMER WAS UNAWARE OF THE MISSING SEGMENTS, BUT NO ADVERSE EVENTS WERE ALLEGED. THE METER IS TO BE RETURNED FOR EVAL. A REPLACEMENT METER 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 7151B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK