BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1000025 · Received February 7, 2008

    Report

    Report Number
    2954323-2008-00752
    Event Type
    Injury
    Date Received
    February 7, 2008
    Date of Event
    December 7, 2007
    Report Date
    February 7, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC. USA
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION AND A FOLLOW-UP WILL BE SUBMITTED ONCE RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HIS TEST STRIPS FOR HIS FREESTYLE FREEDOM METER WERE NOT WORKING PROPERLY AND IT IS REPORTED THAT "HE WAS NOT ABLE TO REGULATE GLUCOSE, (HIS) GLUCOSE LEVEL WENT DANGEROUSLY HIGH LEVELS AND (HE) WAS TAKEN TO A HOSPITAL". HE REPORTS EXPERIENCING "HALLUCINATIONS, BIZARRE BEHAVIOR, CONSTANT URINATION, EXTREME THIRST, CONFUSION" AND THEN STATES HE LOST CONSCIOUSNESS WHILE IN THE HOSPITAL TRIAGE AREA. ALTHOUGH THE CUSTOMER STATES HE WAS DIAGNOSED WITH SEVERE HYPERGLYCEMIA, HE REPORTEDLY WAS TREATED WITH FRUIT JUICE AND DOES NOT RECALL IF HE WAS GIVEN ANY MEDICATION WHILE IN THE HOSPITAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC. USA NI 0706542

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other