BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TS

    MDR report key: 2072600 · Received April 25, 2011

    Report

    Report Number
    1826988-2011-00212
    Event Type
    Malfunction
    Date Received
    April 25, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HER BLOOD GLUCOSE USING HER CONTOUR TS AND CONTOUR METERS. THE CONTOUR TS READ 130 MG/DL, WHILE THE CONTOUR METER READ 66 MG/DL. 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 CUSTOMER DECLINED TO RETURN ANY PRODUCT FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK