BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 3642876 · Received February 24, 2014

    Report

    Report Number
    1826988-2014-00051
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    February 6, 2014
    Report Date
    February 6, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTOUR TEST STRIPS ARE ALSO EXPECTED TO BE RETURNED FOR EVALUATION: LOT# 2KC3F08, EXP DATE 10/31/2014, MANUFACTURE DATE: 10/01/2012, 510(K): K110587. THE MODEL NUMBERS WERE NOT PROVIDED. IN SOME COUNTRIES OUTSIDE THE US, CUSTOMER INFORMATION IS NOT PROVIDED DUE TO PRIVACY LAWS.

    Description of Event or Problem · 1

    A (B)(6) CUSTOMER RAN BLOOD GLUCOSE TESTS ON TWO CONTOUR NEXT LINK METERS AND RECEIVED READINGS OF 287 AND 250MG/DL. THE CUSTOMER RETESTED ON A CONTOUR LINK METER AND THE READING WAS 120MG/DL. THE DIFFERENCES BETWEEN THE READINGS FALL IN THE "C" ZONE 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. NEW METERS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114058 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 3HFED02

    Patients

    Seq Age Sex Outcome Treatment
    1