BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1171249 · Received September 19, 2008

    Report

    Report Number
    2954323-2008-02584
    Event Type
    Injury
    Date Received
    September 19, 2008
    Date of Event
    July 28, 2008
    Report Date
    September 19, 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

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    A CUSTOMER'S WIFE REPORTED SHE TOOK HER HUSBAND, THE USER OF THE METER, TO A VA HOSPITAL AFTER HE BECAME INCOHERENT AND WAS UNABLE TO WALK. AT THE HOSPITAL, THEY OBTAINED THE READING OF 30 MG/DL ON THEIR METER AND WHEN SHE TESTED HIM USING THEIR FREESTYLE FREEDOM METER AT THE SAME TIME, SHE OBTAINED A READING OF 110 MG/DL. THE CUSTOMER WAS TAKEN OFF ALL HIS PILLS AND WAS GIVEN AN INJECTION OF GLUCOSE AND FLUIDS INTRAVENOUSLY. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT.

    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 0802833

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention