BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2000493 · Received January 31, 2011

    Report

    Report Number
    1826988-2011-00037
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 20, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT HE PERFORMED CONTROL TESTS USING HIS CONTOUR METER AND RECEIVED A RESULT OF 284 MG/DL. THE NORMAL CONTROL RANGE WAS NOT PROVIDED, BUT SHOULD BE AROUND 106-147 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER HAD POOR EYESIGHT AND WAS UNABLE TO TROUBLESHOOT DURING THE CALL. HE WAS ADVISED TO RETURN HIS TEST STRIPS FOR EVAL. REPLACEMENT TEST STRIPS AND A NEW METER WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR NBW BAYER HEALTHCARE, LLC 9556C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK