BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2223348 · Received August 16, 2011

    Report

    Report Number
    1826988-2011-00473
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA LAB EVALUATED THE CUSTOMER'S RETURNED REAGENT AND FOUND IT TO READ AN AVERAGE OF 3 MG/DL HIGH, OUT OF SPEC. PERFORMANCE WAS SATISFACTORY USING RETENTION REAGENT.

    Description of Event or Problem · 1

    THE ADVOCATE STATED, THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 245 MG/DL FROM HIS CONTOUR METER AND A READING OF 107 MG/DL FROM ANOTHER 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 RETURNED THE TEST STRIPS FOR EVAL. 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 7080G 1CC3D09

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK