BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE INSULINX

    MDR report key: 5163412 · Received October 20, 2015

    Report

    Report Number
    2954323-2015-00604
    Event Type
    Malfunction
    Date Received
    October 20, 2015
    Date of Event
    August 31, 2015
    Report Date
    December 11, 2015
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    PMA / PMN Number
    K120568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED METER WAS RETURNED AND INVESTIGATED WITH RETAINED TEST STRIPS. THE METER WAS VISUALLY INSPECTED AND NO PHYSICAL DAMAGE WAS OBSERVED. METER POWERED ON WITH BUTTON DEPRESSION AND STRIP INSERTION. A BLANK SCREEN WAS NOT OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION- (B)(4), ON M1G 3M4 UNLESS FURTHER INFORMATION IS OBTAINED, THIS ISSUE IS CONSIDERED CLOSED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692962 FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1