BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 6283319 · Received January 27, 2017

    Report

    Report Number
    2954323-2017-00838
    Event Type
    Malfunction
    Date Received
    January 27, 2017
    Date of Event
    January 17, 2017
    Report Date
    March 29, 2017
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    NBW
    PMA / PMN Number
    K092638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED METER WAS INVESTIGATED WITH RETAINED TEST STRIPS. METER POWERED ON WITH BUTTON DEPRESSION AND TEST STRIP INSERTION. NO NEW ISSUES WERE OBSERVED. BLANK SCREEN WAS NOT OBSERVED. THE COMPLAINT WAS NOT CONFIRMED.

    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. BRAND NAME WAS INCORRECTLY IDENTIFIED AS FREESTYLE FREEDOM LITE. THE CORRECT BRAND NAME FOR THE REPORTED METER SERIAL NUMBER IS (B)(4). BRAND NAME HAS BEEN UPDATED TO REFLECT THE CORRECTION. IN ADDITION PMA/510K# HAS BEEN UPDATED TO K092638 AND CATALOG NO HAS BEEN UPDATED TO 11001-02.

    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
    65668 FREESTYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC 11001-02

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR