BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 1923875 · Received December 8, 2010

    Report

    Report Number
    1826988-2010-00831
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER'S BLOOD GLUCOSE WAS TESTED USING HIS CONTOUR METER AND THE READING WAS 125 MG/DL. HIS GLUCOSE WAS RETESTED USING ANOTHER METER AND THAT READING WAS 272 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 ADVISED TO RETURN HIS TEST STRIPS FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS NBW BAYER HEALTHCARE, LLC 7098C 0DC3A01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK