BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 2842522 · Received November 21, 2012

    Report

    Report Number
    1826988-2012-00623
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER, PHONE AND ADDRESS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE NAME OF THE METER UNDER DESCRIBE EVENT OR PROBLEM, SHOULD BE CONTOUR NEXT LINK

    Description of Event or Problem · 1

    THE ADVOCATE STATED THE CUSTOMER TESTED HIS BLOOD GLUCOSE USING HIS CONTOUR METER AND RECEIVED A READING OF 110MG/DL. HE RETESTED USING ANOTHER METER AND RECEIVED A READING OF 70MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. NO PRODUCTS ARE TO BE RETURNED OR REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7310 2DFEC32

    Patients

    Seq Age Sex Outcome Treatment
    1