BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 3872332 · Received June 13, 2014

    Report

    Report Number
    1826988-2014-00202
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K111268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED ONLY THE CONTOUR BLOOD GLUCOSE TEST STRIPS FOR EVALUATION. MODEL# 7080G, LOT# 3HJ3F02A, EXP DATE 08/31/2015; MANUFACTURE DATE 08/01/2013; 510(K) K062058.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED BLOOD GLUCOSE READINGS OF 191,41 AND 93MG/DL ON THE CONTOUR NEXT EZ METER. HE ALSO RAN TESTS ON THE CONTOUR METER AND THE READINGS WERE 233, 50 AND 108MG/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 CONTOUR NEXT TEST STRIPS WERE EXPECTED TO BE RETURNED FOR EVALUATION BUT CUSTOMER RETURNED ONLY THE CONTOUR TEST STRIPS. REPLACEMENT TEST STRIPS AND METERS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349391 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7313 4AFEC51

    Patients

    Seq Age Sex Outcome Treatment
    1