BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2943978 · Received February 5, 2013

    Report

    Report Number
    1826988-2013-00011
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 7, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED BLOOD GLUCOSE READINGS OF 50, 600 AND 53MG/DL ON HER CONTOUR METER. SHE RETESTED ON A DIFFERENT METER AND THE READINGS WERE 53 AND 329MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "D" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER DECLINED TO TROUBLESHOOT OR PROVIDE ADDITIONAL INFORMATION BEFORE ENDING THE CALL. NO PRODUCT WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48007 CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC 7183

    Patients

    Seq Age Sex Outcome Treatment
    1