BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 3090476 · Received May 2, 2013

    Report

    Report Number
    1826988-2013-00197
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HER BLOOD GLUCOSE USING HER CONTOUR METER AND RECEIVED A READING OF 423MG/DL. SHE WAS ALSO TESTED ON TWO OTHER METERS AND THE READINGS WERE 198 AND 180MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. TEST STRIP INFORMATION WAS NOT PROVIDED. THE STRIPS ARE EXPECTED TO BE RETURNED FOR EVALUATION. NEW METER AND STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191770 CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC 9545C

    Patients

    Seq Age Sex Outcome Treatment
    1