BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 6035234 · Received October 17, 2016

    Report

    Report Number
    2954323-2016-05830
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    October 10, 2016
    Report Date
    November 2, 2016
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    PMA / PMN Number
    K092638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNLESS FURTHER INFORMATION IS OBTAINED, THIS ISSUE IS CONSIDERED CLOSED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS SERVES AS A CORRECTION REPORT. SECTION D1 BRAND NAME WAS INCORRECTLY IDENTIFIED AS (B)(4). THE CORRECT BRAND NAME FOR THE REPORTED METER SERIAL NUMBER IS (B)(4). SECTION D1 BRAND NAME HAS BEEN UPDATED TO REFLECT THE CORRECTION. IN ADDITION SECTION G5 PMA/510K# HAS BEEN UPDATED TO K092638.

    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
    686832 FREESTYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR