BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT LINK

    MDR report key: 3964643 · Received July 29, 2014

    Report

    Report Number
    1826988-2014-00253
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 16, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER INFORMATION WAS NOT PROVIDED IN THE INITIAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HER BLOOD GLUCOSE USING 2 CONTOUR NEXT LINK METERS AND RECEIVED READINGS OF 200 AND 52MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" OR "D" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO EVIDENCE OF AN ADVERSE EVENT WAS ALLEGED. THE TEST STRIPS WERE DISCARDED. REPLACEMENT METER WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441875 CONTOUR NEXT LINK BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC 9632

    Patients

    Seq Age Sex Outcome Treatment
    1