BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TS

    MDR report key: 1508556 · Received October 6, 2009

    Report

    Report Number
    1826988-2009-00872
    Event Type
    Malfunction
    Date Received
    October 6, 2009
    Date of Event
    September 21, 2009
    Report Date
    September 21, 2009
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    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 PERFORMED COMPARISON TESTS USING HER CONTOUR TS AND CONTOUR METERS. THE CONTOUR TS READ 310, 318 AND 319 MG/DL, WHILE THE CONTOUR READ 140, 159 AND 135 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER WAS UNABLE TO TROUBLESHOOT DURING THE CALL. NO PRODUCT WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TS BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 1801 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK