BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 3777197 · Received April 29, 2014

    Report

    Report Number
    1826988-2014-00137
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 2, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K091820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTOUR NEXT TEST STRIPS WERE RETURNED FOR EVALUATION. THE TEST STRIP INFORMATION WAS NOT PROVIDED IN THE INITIAL REPORT. MODEL# 7311, LOT# 3CFEC01, EXPIRATION DATE 03/31/2015. MANUFACTURE DATE 03/01/2013. 510(K) K121190.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 96MG/DL ON THE CONTOUR USB METER, RE-TESTED ON A CONTOUR NEXT AND THE READING WAS 20MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANTNO ADVERSE EVENT WAS ALLEGED.THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION.REPLACEMENT TEST STRIPS AND NEW METER WERE SENT TO THE CUSTOMER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257834 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7080G 3EJ3D01

    Patients

    Seq Age Sex Outcome Treatment
    1