BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 6146534 · Received December 5, 2016

    Report

    Report Number
    2954323-2016-07483
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Date of Event
    November 14, 2016
    Report Date
    April 4, 2017
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHARMACIST

    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. (B)(6).

    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. IN ADDITION PMA/510K# HAS BEEN UPDATED TO K092602, AND CATALOG NO# HAS BEEN UPDATED TO 71501-01.

    Additional Manufacturer Narrative · 1

    THE RETURNED METER WAS INVESTIGATED WITH RETAINED TEST STRIPS. METER POWERED ON WITH BUTTON DEPRESSION AND TEST STRIP INSERTION. AN ERROR MESSAGE WAS OBSERVED UPON BUTTON DEPRESSION AND TEST STRIP INSERTION. THE REPORTED COMPLAINT WAS NOT CONFIRMED.

    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.

    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
    796891 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC 71501-01

    Patients

    Seq Age Sex Outcome Treatment
    1