BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2213859 · Received August 4, 2011

    Report

    Report Number
    1826988-2011-00446
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 11, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 400 MG/DL FROM HER CONTOUR AND A READING OF 147 MG/DL FROM ANOTHER CONTOUR METER. 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. THE ADVOCATE DID NOT HAVE THE TEST STRIPS WITH HER AT THE TIME OF THE CALL. NO PRODUCT IS BEING RETURNED AT THIS TIME. A REPLACEMENT METER WAS SENT TO THE CUSTOMER.

    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