BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2023796 · Received February 15, 2011

    Report

    Report Number
    1826988-2011-00061
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 31, 2011
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE ALLEGED THAT THE CUSTOMER WAS RECEIVING HIGH BLOOD GLUCOSE READINGS. THE ADVOCATE ALSO ALLEGED THAT A CONTROL TEST WAS PERFORMED USING THE CUSTOMER'S CONTOUR METER AND THE RESULT WAS 230 MG/DL. THE NORMAL CONTROL RANGE WAS 102-141 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE ADVOCATE DECLINED TO TROUBLESHOOT OR RETURN PRODUCT BEFORE ENDING THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR NBW BAYER HEALTHCARE, LLC 9678 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK