BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 4140709 · Received October 3, 2014

    Report

    Report Number
    1826988-2014-00341
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K111268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MODEL# WAS NOT PROVIDED. IN SOME COUNTRIES OUTSIDE THE US, CUSTOMER INFORMATION IS NOT PROVIDED DUE TO PRIVACY LAWS.

    Description of Event or Problem · 1

    (B)(6) CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 497MG/DL ON THE CONTOUR XT METER, RE-TESTED ON A DIFFERENT METER AND THE READING WAS 228MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE TEST STRIPS ARE EXPECTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620875 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 3AFED01

    Patients

    Seq Age Sex Outcome Treatment
    1