BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2132361 · Received June 13, 2011

    Report

    Report Number
    1826988-2011-00327
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 17, 2011
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K060470
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL CALLED FOR HELP WITH THE CUSTOMER'S CONTOUR METERS. THE CUSTOMER TESTED HIS BLOOD GLUCOSE USING BOTH METERS AND RECEIVED READINGS OF 201 AND 89 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 CALLER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION, BUT THEY WERE NOT RECEIVED BY THE QA LAB. 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 NBW BAYER HEALTHCARE, LLC 7151 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK