BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT EZ

    MDR report key: 3901538 · Received June 30, 2014

    Report

    Report Number
    1826988-2014-00218
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 8, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K111268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER OPENED A NEW CARTON OF CONTOUR NEXT TEST STRIPS AND FOUND THE CAP OPEN ON THE BOTTLE OF STRIPS.NO ADVERSE EVENTS WERE ALLEGED.THE TEST STRIPS WERE DISCARDED BY THE CUSTOMER, SO STRIP INFORMATION COULD NOT BE PROVIDED. REPLACEMENT STRIPS WERE SENT TO HIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379040 CONTOUR NEXT EZ BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC 9628

    Patients

    Seq Age Sex Outcome Treatment
    1