BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 4122622 · Received September 26, 2014

    Report

    Report Number
    1826988-2014-00327
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 6, 2014
    Report Date
    September 12, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K121087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN SOME COUNTRIES OUTSIDE THE US, CUSTOMER INFORMATION IS NOT PROVIDED DUE TO PRIVACY LAWS.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STRIPS WERE RETURNED FOR EVALUATION. ALTHOUGH IT COULD NOT BE DETERMINED IF THE BOTTLE CAP WAS ALREADY OPEN WHEN THE CUSTOMER GOT THEM, THE STRIPS GAVE SATISFACTORY PERFORMANCE WHEN TESTED WITH CONTROL SOLUTION.

    Description of Event or Problem · 1

    A (B)(6) CUSTOMER OPENED A NEW BOX OF CONTOUR NEXT TEST STRIPS AND FOUND THE STRIP BOTTLE WAS OPEN. NO ADVERSE EVENT WAS ALLEGED. THE STRIPS ARE EXPECTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602078 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 4DFEF07

    Patients

    Seq Age Sex Outcome Treatment
    1