BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1171250 · Received September 19, 2008

    Report

    Report Number
    2954323-2008-02585
    Event Type
    Injury
    Date Received
    September 19, 2008
    Date of Event
    August 19, 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. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. THE FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATIONAL RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED SHE WAS USING IMPROPERLY CALIBRATED METER THAT WAS GIVING HER INCORRECT READINGS AND AS A RESULT SHE EXPERIENCED HYPOGLYCEMIC EPISODE AND HAD A SEIZURE. PARAMEDICS WERE CALLED AND TREATED HER WITH GLUCOSE GEL. ADDITIONALLY, SHE SELF-TREATED WITH GLUCAGON AND FOOD TO BRING HER BLOOD GLUCOSE UP. 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 MONITORIG SYSTEM LFR ABBOTT DIABETES CARE INC, USA NI 0804624

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention