BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2231290 · Received July 25, 2011

    Report

    Report Number
    1826988-2011-00426
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 30, 2011
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) CUSTOMER TESTED HIS BLOOD GLUCOSE USING HIS CONTOUR LINK AND CONTOUR METERS. THE LINK METER READ 13.1 MMOL/L, WHILE THE CONTOUR READ 3.1 MMOL/L. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "D" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN HIS TEST STRIPS FOR EVAL. REPLACEMENT TEST STRIPS AND A NEW METER WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS NBW BAYER HEALTHCARE LLC NOT PROVIDED 0JC3D07

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK