BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2063090 · Received April 11, 2011

    Report

    Report Number
    1826988-2011-00180
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 13, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THE CUSTOMER RECEIVED BLOOD GLUCOSE READINGS OF 279 AND 280 MG/DL FROM HER CONTOUR AND READINGS OF 105 AND 130 MG/DL FROM ANOTHER 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 PERFORMED A CONTROL TEST DURING THE CALL AND THE RESULT FELL WITHIN THE NORMAL CONTROL RANGE. NO PRODUCT WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR NBW BAYER HEALTHCARE LLC 7189 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK