BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2121509 · Received May 6, 2011

    Report

    Report Number
    1826988-2011-00226
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED, THE CUSTOMER TESTED HIS BLOOD GLUCOSE AND RECEIVED READINGS BETWEEN 170-180 MG/DL USING HIS CONTOUR METER AND A READING OF 400 MG/DL FROM HIS CONTOUR USB METER. ON ANOTHER OCCASION, THE CONTOUR METER READ 30 MG/DL, WHILE THE USB METER READ 103 MG/DL. THE DIFFERENCE BETWEEN BOTH SETS OF READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED AS A RESULT OF THE READINGS. DURING THE CALL, THE ADVOCATE PERFORMED CONTROL TESTS AND RECEIVED RESULTS OF 239 AND 202 MG/DL. THE NORMAL CONTROL RANGE WAS 104-143 MG/DL. THE ADVOCATE USED THE LAST OF THE TEST STRIPS WHILE TROUBLESHOOTING, SO NO PRODUCT WILL BE RETURNED. REPLACEMENT METERS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR NBW BAYER HEALTHCARE, LLC 9680 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK