BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 6180665 · Received December 16, 2016

    Report

    Report Number
    1826988-2016-00471
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    December 4, 2016
    Report Date
    December 4, 2016
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    JJX
    PMA / PMN Number
    K111268
    Removal / Correction Number
    Z-2482-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED AN OUT OF RANGE CONTROL RESULT ON THE CONTOUR NEXT EZ. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, WHICH WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER MEMORY. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE CONTROL FOR EVALUATION. NEW STRIPS, METERS AND CONTROL WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833300 CONTOUR NEXT QUALITY CONTROL MATERIAL JJX ASCENSIA DIABETES CARE US INC. 7314 6BV2A02

    Patients

    Seq Age Sex Outcome Treatment
    1