BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1012322 · Received February 11, 2008

    Report

    Report Number
    2954323-2008-01038
    Event Type
    Injury
    Date Received
    February 11, 2008
    Date of Event
    February 12, 2008
    Report Date
    March 11, 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'S DAUGHTER REPORTED CUSTOMER RECEIVED INACCURATE HIGH GLUCOSE READING (400 MG/DL) FROM THEIR FREESTYLE FREEDOM METER. CUSTOMER'S DAUGHTER REPORTED CUSTOMER EXPERIENCED SYMPTOMS OF FAINTING AND LOSS OF CONSCIOUSNESS. PARAMEDICS WERE CALLED AND OBTAINED A GLUCOSE READING OF 53 MG/DL WITH THEIR HCP METER. CUSTOMER WAS THEN TRANSPORTED TO KAISER HOSPITAL WHERE SHE WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND BEING TREATED WITH SUGAR WATER AND FOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC. NA 0720229

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R