BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2842392 · Received November 21, 2012

    Report

    Report Number
    1826988-2012-00616
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER WAS EVALUATED BY QA AND IT WAS FOUND THAT THE DISPLAY SEGMENTS "B" AND "G" WERE MISSING IN ALL POSITIONS AND IN THE TIME/DATE AREA. CORRECTED SERIAL NUMBER TO (B)(4) AND MANUFACTURE DATE TO 06/06/2011

    Description of Event or Problem · 1

    THE CUSTOMER STATED HER NEW METER WAS BROKEN, AND DURING THE CALL IT WAS DISCOVERED THAT SEGMENT "D" OF THE UNITS, TENS AND HUNDREDS COLUMNS WAS MISSING. THERE WAS NO ADVERSE EVENT ALLEGED. THE METER WAS REPLACED AND THE CUSTOMER IS EXPECTED TO RETURN HER METER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC 7151H

    Patients

    Seq Age Sex Outcome Treatment
    1