BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1000027 · Received February 7, 2008

    Report

    Report Number
    2954323-2008-00726
    Event Type
    Injury
    Date Received
    February 7, 2008
    Date of Event
    January 2, 2008
    Report Date
    February 7, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC.
    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 EXPERIENCING PASSING OUT WHILE AT WORK. CUSTOMER REPORTED HIS BOSS TOOK HIM TO HIS OFFICE AND GAVE HIM CANDY BAR AND WATER TO COUNTERACT HIS SYMPTOMS. CUSTOMER WAS THEN ABLE TO RETURN TO WORK. CUSTOMER ALSO REPORTED A BLANK SCREEN ON HIS METER BUT IT IS UNCLEAR IF THIS WAS BEFORE OR AFTER THE REPORTED MEDICAL EVENT. THERE IS NO REPORT OF THIRD PARTY MEDICAL INTERVENTION OR DIAGNOSIS OF HYPER/HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC. NA 0624248

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Other