BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1066423 · Received July 1, 2008

    Report

    Report Number
    2954323-2007-10627
    Event Type
    Injury
    Date Received
    July 1, 2008
    Date of Event
    May 10, 2007
    Report Date
    June 15, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 290 MG/DL ON THEIR FREESTYLE FREEDOM BLOOD GLUCOSE MONITOR. CUSTOMER THEN REPORTED TAKING AN UNSPECIFIED PILL, AND THEN APPROXIMATELY THREE HOURS LATER RECEIVED AND ADDITIONAL GLUCOSE RESULT OF 34 MG/DL AND REPORTED TO HAVE FELT DIZZY, LIGHT HEADED, BLURRED VISION, AND THEN REPORTED TO LOST CONSCIOUSNESS. THE CUSTOMERS CO-WORKER CALLED 911 AND ADMINISTERED A GLUCOSE PILL. CUSTOMER REGAINED CONSCIOUSNESS AFTER APPROXIMATELY 20-30 MINUTES. WHEN PARAMEDICS ARRIVED CUSTOMERS GLUCOSE LEVELS HAD STABILIZED, NO TREATMENT WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC NI 0630031

    Patients

    Seq Age Sex Outcome Treatment
    1