BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1171224 · Received September 17, 2008

    Report

    Report Number
    2954323-2008-02570
    Event Type
    Injury
    Date Received
    September 17, 2008
    Date of Event
    August 18, 2008
    Report Date
    September 17, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC GLUCOSE READINGS FROM THEIR FREESTYLE FREEDOM LITE METER. CUSTOMER REPORTED LOSS OF CONSCIOUSNESS WHILE SLEEPING AND EATING FOOD TO COUNTERACT HER SYMPTOMS. PARAMEDICS WERE CALLED AND TREATED CUSTOMER WITH INTRAVENOUS GLUCOSE. THERE IS NO REPORT OF ANY DIAGNOSIS, AN INVESTIGATION INTO THE DETAILS OF THIS EVENT IS IN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NA 0819724

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention