BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 1960167 · Received December 15, 2010

    Report

    Report Number
    1826988-2010-00845
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 6, 2010
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) CUSTOMER TESTED HER BLOOD GLUCOSE AND RECEIVED A READING OF 3.9 MMOL/L USING HER CONTOUR LINK METER. SHE RETESTED USING ANOTHER METER AND RECEIVED A READING OF 15.9 MMOL/L. 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 WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT 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 0BC3C13

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK