BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2212081 · Received July 8, 2011

    Report

    Report Number
    1826988-2011-00385
    Event Type
    Malfunction
    Date Received
    July 8, 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

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER FOR OTHER CONTOUR METER: (B)(4). MANUFACTURE DATE 01/2010.

    Description of Event or Problem · 1

    THE ADVOCATE STATED THE CUSTOMER'S BLOOD GLUCOSE WAS TESTED USING 2 CONTOUR METERS AND HE RECEIVED READINGS OF 533 AND 127 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 ADVOCATE WAS ADVISED TO RETURN THE CUSTOMER'S TEST STRIPS FOR EVALUATION, BUT THEY WERE NOT RECEIVED BY THE QA LAB. REPLACEMENT METERS AND TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR NBW BAYER HEALTHCARE LLC. NOT PROVIDED NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK