BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 1190347 · Received October 6, 2008

    Report

    Report Number
    2954323-2008-02676
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 6, 2008
    Report Date
    October 6, 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 REPORTED AN ERROR 4 MESSAGE ON THEIR FREESTYLE FLASH METER IN THE FIRE DEPARTMENT. CUSTOMER REPORTED THE ERROR HAPPENED WHEN HE TRIED TO OBTAIN A READING FROM A PATIENT WHO HAS DECREASED LEVEL OF CONSCIOUSNESS. CUSTOMER REPORTED TREATING THE PATIENT WITH INTRAVENOUS SOLUTION AND OXYGEN, THEN TRANSPORTING THE PATIENT TO A LOCAL HOSPITAL. THERE IS NO REPORT OF HYPER OR HYPOGLYCEMIA DIAGNOSIS OR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NA 0807607

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention