BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT LINK

    MDR report key: 4943821 · Received July 27, 2015

    Report

    Report Number
    1826988-2015-00364
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Date of Event
    April 15, 2015
    Report Date
    July 6, 2015
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A CONTROL READING THAT WAS NOT AUTOMATICALLY MARKED BY THE CONTOUR NEXT LINK AS A CONTROL TEST, WHICH WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. NO ADVERSE EVENT WAS ALLEGED. TEST STRIP INFORMATION WAS NOT PROVIDED. NEW METER AND CONTROL WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487711 CONTOUR NEXT LINK BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC 9632

    Patients

    Seq Age Sex Outcome Treatment
    1