BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 3090485 · Received May 2, 2013

    Report

    Report Number
    1826988-2013-00198
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED ABOUT INCONSISTENT READINGS ON HER CONTOUR METER. WHILE TROUBLESHOOTING, IT WAS DISCOVERED THERE WERE SOME MISSING SEGMENTS. NO ADVERSE EVENT WAS ALLEGED. METER WAS REPLACED. CUSTOMER WAS ADVISED TO RETURN HER METER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191772 CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC 9556C

    Patients

    Seq Age Sex Outcome Treatment
    1