BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 3812057 · Received May 15, 2014

    Report

    Report Number
    1826988-2014-00176
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 26, 2014
    Report Date
    April 29, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED BLOOD GLUCOSE READINGS OF 386-417MG/DL ON HER CONTOUR NEXT LINK. SHE RETESTED ON ANOTHER CONTOUR NEXT LINK AND RECEIVED READINGS OF 40, 43, 38, 42, 56MG/DL. SHE THEN TESTED ON A NON BAYER METER AND THE READING WAS 160MG/DL. THE DIFFERENCES BETWEEN THE READINGS FALL IN THE "C", "D", "E" ZONES OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCES CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER TEST STRIPS ARE EXPECTED TO BE RETURNED FOR EVALUATION. NEW STRIPS WERE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289996 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7310 2JFEC32

    Patients

    Seq Age Sex Outcome Treatment
    1