BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 3120157 · Received May 20, 2013

    Report

    Report Number
    1826988-2013-00230
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 554MG/DL ON THE CONTOUR METER, RE-TESTED ON A DIFFERENT METER AND THE READING WAS 120MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "D" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE METER WAS REPLACED AT THE REQUEST OF THE CUSTOMER. TEST STRIP INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222564 CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC 9545C

    Patients

    Seq Age Sex Outcome Treatment
    1