BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1480367 · Received September 18, 2009

    Report

    Report Number
    2954323-2009-01740
    Event Type
    Injury
    Date Received
    September 18, 2009
    Date of Event
    August 18, 2009
    Report Date
    September 18, 2009
    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 A FINAL REPORT. THE DEVICE AND TEST STRIPS (LOT NO: 0913101) WERE RETURNED AND AN INVESTIGATION USING APPROVED CONTROL SOLUTION DETERMINED THE COMPLAINT IS NOT CONFIRMED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION DURING CONTROL SOLUTION TESTING. A REVIEW OF THE METER'S INTERNAL MEMORY LOG REVEALED A RESULT OF 90 MG/DL IN 2009. IT SHOULD BE NOTED: WHILE TROUBLESHOOTING WITH CUSTOMER SERVICE, IT WAS DISCOVERED THE CUSTOMER DID NOT WASH PRIOR TO TESTING WHICH MAY CAUSE IMPRECISE READINGS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED WAKING UP AT 2:30 AM IN 2009, AND USING HER WALKER, FELL, INJURING HER KNEE, WHILE WALKING TOWARDS THE BATHROOM. SHE NOTED SHE HAD NO OTHER SYMPTOMS TO REPORT. SHE DENIED FEELING LIGHTHEADED, WEAK OR NAUSEOUS. SHE FURTHER NOTED HER HUSBAND CHECKED HER GLUCOSE USING HER FREESTYLE FREEDOM LITE BLOOD GLUCOSE METER AND RECEIVED A RESULT OF 90 MG/DL. PARAMEDICS WERE CALLED AND THEY RECEIVED A RESULT OF 42 MG/DL, APPROXIMATELY 30 TO 45 MINUTES LATER. CUSTOMER INITIALLY REFUSED TO BE TRANSPORTED TO A LOCAL EMERGENCY ROOM BECAUSE SHE NOTED SHE FELT FINE. SHE LATER AGREED AND WAS GIVEN "SUGAR STUFF" BY THE PARAMEDICS. AT THE HOSPITAL SHE WAS DIAGNOSED WITH HYPOGLYCEMIA AND GIVEN ADDITIONAL GLUCOSE VIA INTRAVENOUS INFUSION. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC., USA NI 0913101

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R