BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 4999563 · Received August 13, 2015

    Report

    Report Number
    1826988-2015-00384
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 29, 2015
    Report Date
    July 29, 2015
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE MODEL# (D4) WAS NOT PROVIDED. IN SOME COUNTRIES OUTSIDE THE US, CUSTOMER INFORMATION IS NOT PROVIDED DUE TO PRIVACY LAWS.

    Additional Manufacturer Narrative · 1

    CORRECTIONS: THE NAME OF THE METER IN DESCRIPTION OF EVENT OR PROBLEM, SHOULD BE CONTOUR NEXT LINK 2.4. THE PRODUCT DOES NOT HAVE 510(K)#. IT IS AWAITING PMA.

    Description of Event or Problem · 1

    (B)(6) CUSTOMER RAN A CONTROL TEST ON THE CONTOUR NEXT LINK. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, WHICH WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. NEW STRIPS AND CONTROL WERE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532962 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 5CFEF07

    Patients

    Seq Age Sex Outcome Treatment
    1