BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1241259 · Received November 18, 2008

    Report

    Report Number
    2954323-2008-02884
    Event Type
    Injury
    Date Received
    November 18, 2008
    Date of Event
    October 23, 2008
    Report Date
    November 18, 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'S GIRLFRIEND REPORTED CUSTOMER RECEIVED HIGH GLUCOSE READING FROM THEIR FREESTYLE LITE METER AND CUSTOMER SELF-ADMINISTERED WITH EXTRA DOSAGE OF INSULIN. CUSTOMER'S GIRLFRIEND REPORTED AFTER THE INSULIN TREATMENT CUSTOMER BECAME UNRESPONSIVE. PARAMEDICS WERE CALLED AND TREATED CUSTOMER WITH "SUGAR WATER" INTRAVENOUSLY AND FOOD. IT IS UNCLEAR WHAT READING THE CUSTOMER OBTAINED PRIOR TO HIS EVENT. THERE IS NO REPORT OF DEATH OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NA 0810805

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention