BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 1060676 · Received June 13, 2008

    Report

    Report Number
    2954323-2008-02116
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 16, 2008
    Report Date
    June 13, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 REPORTED RECEIVING A GLUCOSE RESULT OF HI (>500 MG/DL) ON THEIR FREESTYLE FLASH BLOOD GLUCOSE MONITOR. SHE THEN REPORTED FEELING LETHARGIC, SHAKY, CONFUSED, AND JERKING IN HER ARMS AND LEGS. CUSTOMER STATED SHE FELT LIKE HER "SUGAR DROPPED". THE CUSTOMER REPORTED EXPERIENCING A SEIZURE AND A LOSS OF CONSCIOUSNESS. CUSTOMER REPORTED SELF-TREATING WITH METFORMIN. NO REPORT OF DEATH OR PERMANENT IMPAIRMENT WAS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NI 0800320

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other