BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 4805114 · Received May 29, 2015

    Report

    Report Number
    1826988-2015-00250
    Event Type
    Malfunction
    Date Received
    May 29, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 11, 2015
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED HER SON'S BLOOD GLUCOSE WAS TESTED ON 2 CONTOUR NEXT LINK METERS AND A CONTOUR NEXT USB. HIS READINGS WERE 100, 172 AND OVER 600MG/DL. THE READINGS FROM A SEPARATE COMPARISON BETWEEN TWO OF THE BAYER METERS WERE 54 AND 145MG/DL. THE DIFFERENCES BETWEEN THE READINGS FALL IN THE "C" AND "D" ZONES OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCES CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE TEST STRIPS WERE EXPECTED TO BE RETURNED FOR EVALUATION. NEW METER AND STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350809 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7308 4LFED01

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR