BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1080179 · Received July 21, 2008

    Report

    Report Number
    2954323-2008-02292
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    May 22, 2008
    Report Date
    July 21, 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 A HIGH GLUCOSE READING (341 MG/DL) FROM THEIR FREESTYLE FREEDOM METER AND SELF-ADMINISTERED HIMSELF WITH 130 UNITS OF INSULIN. CUSTOMER REPORTED ONE EPISODE OF LOSING CONSCIOUSNESS AND DENIED EXPERIENCING ANY SYMPTOMS PRIOR. PARAMEDICS WERE CALLED AND TREATED CUSTOMER WITH ORANGE JUICE. CUSTOMER WAS THEN TRANSPORTED TO HOSPITAL. THERE WAS NO REPORT OF DIAGNOSIS OR TREATMENT AT THE HOSPITAL, 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 BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NA 0806533

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization