BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 1030261 · Received April 17, 2008

    Report

    Report Number
    2954323-2008-01500
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    March 17, 2008
    Report Date
    April 17, 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 SUBMITTED IF THE METER IS RETURNED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING A READING OF 243 MG/DL ON HER FREESTYLE FLASH BLOOD GLUCOSE METER, TAKING A SHOT OF INSULIN, BECOMING INCOHERENT AND DROWSY AND THEN LOSING CONSCIOUSNESS. WHEN SHE WOKE UP, SHE WAS REPORTEDLY BEING ASSISTED BY PARAMEDICS WHO TREATED HER WITH AN INTRAVENOUS SOLUTION OF VITAMIN B1 OR B12. THE PARAMEDICS ALSO TOOK A REPORTED BLOOD GLUCOSE READING OF 43 MG/DL. 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 0631829

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention