BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2994072 · Received March 8, 2013

    Report

    Report Number
    1826988-2013-00079
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 12, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER PHONE AND ADDRESS WERE NOT PROVIDED.

    Description of Event or Problem · 1

    THE ADVOCATE STATED THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 460 MG/DL FROM THE CONTOUR METER, RE-TESTED ON A DIFFERENT METER AND RECEIVED 121 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 CUSTOMER HAS NO STRIPS LEFT TO RETURN FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99854 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7080G 1LC3B12

    Patients

    Seq Age Sex Outcome Treatment
    1