BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 5077180 · Received September 15, 2015

    Report

    Report Number
    1826988-2015-00469
    Event Type
    Malfunction
    Date Received
    September 15, 2015
    Date of Event
    August 28, 2015
    Report Date
    August 28, 2015
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K111268
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    2 OF THE 4 BOTTLES RETURNED BY THE CUSTOMER READ HIGH OUT OF SPEC WITH BLOOD & CONTROL; ONE BOTTLE READ AN AVERAGE OF 65MG/DL OUT OF SPEC USING CONTROL, AND AN AVERAGE OF 76MG/DL OUT OF SPEC WITH BLOOD. THE SECOND BOTTLE READ AN AVERAGE 9MG/DL OUT OF SPEC WITH CONTROL, AND AN AVERAGE 8MG/DL OUT OF SPEC. WITH BLOOD.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED HIGH READING USING HER CONTOUR NEXT EZ METER. NO ADVERSE EVENTS ALLEGED. THE COMPLAINT DID NOT MEET THE CRITERIA TO BE REPORTED AT THE TIME OF THE CALL, BUT THE TEST STRIPS WERE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608145 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7309 4LFEF04

    Patients

    Seq Age Sex Outcome Treatment
    1