BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT USB

    MDR report key: 3982688 · Received July 22, 2014

    Report

    Report Number
    1826988-2014-00246
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 4, 2014
    Report Date
    July 10, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K121087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL # WAS NOT PROVIDED. IN SOME COUNTRIES OUTSIDE THE U.S, CUSTOMER INFO IS NOT PROVIDED DUE TO PRIVACY LAWS.

    Description of Event or Problem · 1

    A NURSE FROM PORTUGAL RETURNED A CONTOUR NEXT USB METER TO A BAYER SALES REP BECAUSE THE PT HAD RUN SOME BLOOD TESTS ON THE METER THAT WERE NOT RETAINED IN THE MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE METER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429080 CONTOUR NEXT USB BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1