BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1004037 · Received February 27, 2008

    Report

    Report Number
    2954323-2008-00922
    Event Type
    Injury
    Date Received
    February 27, 2008
    Date of Event
    December 27, 2007
    Report Date
    February 27, 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 RETURNED AND AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    CUSTOMER'S DAUGHTER REPORTED CUSTOMER EXPERIENCED TWO INCIDENTS DUE TO AN ERRC 2 MESSAGE WHICH APPEARED ON THEIR FREESTYLE FREEDOM METER. CUSTOMER'S DAUGHTER REPORTED CUSTOMER EXPERIENCED SYMPTOMS OF "CONFUSION, FELL ASLEEP, LIGHT HEADEDNESS, EXCESSIVE SWEATING AND LOSS OF CONSCIOUSNESS"; HOWEVER, IT IS NOT CLEAR WHICH SYMPTOM THE CUSTOMER WAS EXPERIENCING AT EACH EVENT. IN ONE INCIDENT, PER CUSTOMER'S DAUGHTER, CUSTOMER EXPERIENCED SYMPTOMS OF HYPERGLYCEMIA AND PARAMEDICS WERE CALLED AND TREATED CUSTOMER WITH INTRAVENOUS INSULIN. IN THE OTHER REPORTED INCIDENT CUSTOMER EXPERIENCED HYPOGLYCEMIA AND SELF-TREATED WITH A CANDY BAR, PEANUT BUTTER, JELLY AND HONEY TO COUNTERACT HER SYMPTOMS. THERE IS NO REPORT OF ANY DIAGNOSIS, AN INVESTIGATION INTO THE DETAILS 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 0710717

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention