BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2994078 · Received March 8, 2013

    Report

    Report Number
    1826988-2013-00087
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 18, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 145MG/DL ON A NON-BAYER METER, RE-TESTED ON THE CONTOUR METER AND THE READING WAS 348MG/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 CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98964 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7097C 1MC3A03

    Patients

    Seq Age Sex Outcome Treatment
    1