BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT EZ

    MDR report key: 4251656 · Received November 14, 2014

    Report

    Report Number
    1826988-2014-00410
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 24, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K111268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTOUR NEXT TEST STRIP INFORMATION WAS NOT PROVIDED IN THE INITIAL REPORT. THE TEST STRIPS WERE RETURNED FOR EVALUATION. LOT# 4EFEB07, EXPIRATION DATE 05/31/2016. MANUFACTURE DATE 05/01/2014.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF LO ON THE CONTOUR NEXT EZ, RE-TESTED ON A DIFFERENT METER AND THE READING WAS 133MG/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 TEST STRIP INFORMATION WAS INVALID. A NEW METER WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736411 CONTOUR NEXT EZ BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC 7252

    Patients

    Seq Age Sex Outcome Treatment
    1