BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 3811893 · Received May 15, 2014

    Report

    Report Number
    1826988-2014-00170
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K121087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    (B)(6) CUSTOMER OPENED A NEW CONTOUR NEXT USB KIT AND FOUND THE CAP OPEN ON THE SAMPLE BOTTLE OF TEST STRIPS. THE BOX OF STRIPS WAS SEALED. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291838 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 3FFED31

    Patients

    Seq Age Sex Outcome Treatment
    1