BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 1171245 · Received September 18, 2008

    Report

    Report Number
    2954323-2008-02573
    Event Type
    Injury
    Date Received
    September 18, 2008
    Date of Event
    August 21, 2008
    Report Date
    September 18, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE DEVICE HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A "HI" (INDICATES A READING GREATER THAN 500 MG/DL) ON THE DISPLAY OF HER FREESTYLE METER AND SUBSEQUENTLY LOSING CONSCIOUSNESS. PARAMEDICS WERE CALLED AND TRANSPORTED CUSTOMER TO COLUMBIA MEMORIAL HOSPITAL EMERGENCY ROOM WHERE SHE WAS DIAGNOSED WITH HYPOGLYCEMIA. CUSTOMER ALSO REPORTED HER BLOOD GLUCOSE WAS 59 MG/DL AT THE HOSPITAL. CUSTOMER WAS TREATED WITH AN INTRAVENOUS OF "SUGAR WATER" AND GIVEN FOOD TO EAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NI 0810620

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention