BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2201084 · Received July 1, 2011

    Report

    Report Number
    1826988-2011-00381
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 13, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THAT SHE RECEIVED BLOOD GLUCOSE READINGS OF 300 AND 280 MG/DL USING HER CONTOUR METER AND A READING OF 142 MG/DL USING THE CUSTOMER'S CONTOUR METER. 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 ADVOCATE WAS ADVISED TO RETURN THE TEST STRIPS FOR EVAL. REPLACEMENT TEST STRIPS AND A NEW METER WERE SENT TO THE ADVOCATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS NBW BAYER HEALTHCARE, LLC 7098C 0J3C07

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK