BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 1002469 · Received February 20, 2008

    Report

    Report Number
    2954323-2008-00847
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    December 6, 2007
    Report Date
    February 20, 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

    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

    A CUSTOMER REPORTED THAT THE BATTERIES IN THEIR FREESTYLE FLASH BLOOD GLUCOSE MONITOR HAD "DRAINED" AND THE METER WOULD NOT PROPERLY POWER ON. AS A RESULT, THE CUSTOMER REPORTED NOT BEING ABLE TO TEST, AND REPORTED FEELING THIRSTY, SWEATY, CLAMMY, DIZZY, AND LIKE THEY NEEDED TO FREQUENTLY URINATE. HE THEN REPORTED EXPERIENCING A SEIZURE. HE HIT HIS HEAD SOMETIME DURING THE COURSE OF THE SEIZURE, AND PARAMEDICS WERE CALLED. HE WAS TRANSPORTED TO A LOCAL HOSPITAL WHERE HE WAS DIAGNOSED WITH SEVERE HYPERGLYCEMIA. INSULIN WAS ADMINISTERED IN ORDER TO STABILIZE GLUCOSE LEVELS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT 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 NA 0724229

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Hospitalization SIMVASTATIN| ZETIA| PHENYTOIN| LABETALOL| HYDROCHLOROHIAZIDE