BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1082244 · Received July 22, 2008

    Report

    Report Number
    2954323-2008-02302
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 25, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION AND A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING IMPRECISE METER READINGS ON THEIR FREESTYLE FREEDOM METER AND STATED THEY HAD (2) EVENTS OF LOSING CONSCIOUSNESS WHILE AT HOME. THEY REPORTED READINGS OF 99 MG/DL, 98 MG/DL, 147 MG/DL, 67 MG/DL, 66 MG/DL, 105 MG/DL, 104 MG/DL, 195 MG/DL, 88 MG/DL, AND 166 MG/DL. ALL READINGS FELL WITHIN THE "B" ZONE ON THE PARKES ERROR GRID, SHOWING THE DIFFERENCE IN VALUES ARE NOT CONSIDERED CLINICALLY SIGNIFICANT. DURING THE FIRST EVENT REPORTED, PARAMEDICS WERE CALLED, TREATED THE CUSTOMER WITH GLUCOGON INJECTION ON SCENE AND TRANSPORTED CUSTOMER TO A LOCAL HOSPITAL. HE WAS DIAGNOSED WITH HYPOGLYCEMIA AND TREATED WITH FOOD/DRINK AT THE HOSPITAL. ON THE SECOND EVENT REPORTED, CUSTOMER WAS GIVEN ICING AND SODA BY HIS DAUGHTER TO WAKE HIM UP. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THESE EVENTS.

    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 0809014

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention