BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 4140738 · Received October 3, 2014

    Report

    Report Number
    1826988-2014-00345
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 14, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER RECEIVED BLOOD GLUCOSE READINGS OF 600, 592, 384 MG/DL FROM HER CONTOUR AND READINGS OF APPROXIMATELY 84-112 MG/DL FROM ANOTHER METER. THE DIFFERENCES BETWEEN THE READINGS FALL INTO THE "C" AND "D" ZONES OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCES CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT TEST STRIPS AND METER WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620457 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7080G 3DJ3A04

    Patients

    Seq Age Sex Outcome Treatment
    1