BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR USB

    MDR report key: 3070031 · Received April 22, 2013

    Report

    Report Number
    1826988-2013-00174
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K091820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED HIS SON RECEIVED A BLOOD GLUCOSE READING OF 158MG/DL FROM THE CONTOUR USB METER,WAS RE-TESTED ON THE DOCTOR'S EQUIPMENT AND RECEIVED 399MG/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 AT THE REQUEST OF THE ADVOCATE, THE METER WAS REPLACED TEST STRIP INFORMATION WAS NOT PROVIDED AND THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173154 CONTOUR USB BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC 7393A

    Patients

    Seq Age Sex Outcome Treatment
    1