BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 6119219 · Received November 21, 2016

    Report

    Report Number
    2954323-2016-06837
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    December 6, 2016
    Report Date
    March 28, 2017
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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 REPORT IS BEING FILED AS A CORRECTION. THE REPORTED ¿REPORT DATE¿ WAS INCORRECT ON THE INITIAL SUBMISSION. THE CORRECT REPORT DATE IS 11/21/2016.

    Additional Manufacturer Narrative · 1

    THIS SERVES AS A CORRECTION REPORT. BRAND NAME WAS INCORRECTLY IDENTIFIED AS FREESTYLE FREEDOM LITE. THE CORRECT BRAND NAME FOR THE REPORTED METER SERIAL NUMBER IS FREESTYLE LITE. BRAND NAME HAS BEEN UPDATED TO REFLECT THE CORRECTION. IN ADDITION PMA/510K# HAS BEEN UPDATED TO K092602.

    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
    770124 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR