BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 1000067 · Received February 15, 2008

    Report

    Report Number
    2954323-2008-00814
    Event Type
    Injury
    Date Received
    February 15, 2008
    Date of Event
    December 3, 2007
    Report Date
    February 15, 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 CALLED FOR HELP IN SETTING UP HIS FREESTYLE FLASH BLOOD GLUCOSE MONITOR. HE REPORTED THAT HE WAS UNABLE TO TEST BECAUSE HE COULD NOT PROPERLY CALIBRATE HIS METER. HE REPORTED THAT AS A RESULT OF NOT BEING ABLE TO PROPERLY TEST, HE EXPERIENCED HEADACHES AND PAIN THROUGHOUT HIS BODY. THE CUSTOMER WENT TO A LOCAL HOSPITAL WHERE HIS SUGAR REGISTERED AT 500 MG/DL. HE REPORTED BEING GIVEN AN IV TREATMENT OF BLOOD THINNERS, AND HIS GLUCOSE THEN REGISTERED AT 27 MG/DL. HE WAS PRESCRIBED INSULIN IN ORDER TO STABILIZE HIS GLUCOSE IN THE FUTURE. 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 0723616

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention