BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 1211204 · Received October 23, 2008

    Report

    Report Number
    2954323-2008-02761
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    August 24, 2008
    Report Date
    October 23, 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 MOTHER REPORTED CUSTOMER RECEIVED ERRATIC GLUCOSE READINGS (246 MG/DL AND 320 MG/DL) FROM THEIR FREESTYLE FLASH METER. CUSTOMER'S MOTHER REPORTED CUSTOMER SUFFERED ONE EPISODE OF SEIZURE AND BEING TREATED WITH GLUCAGONS BY HER MOTHER. THERE IS NO REPORT OF ANY DIAGNOSIS, DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS CASE.

    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 0806432

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention