BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1659174 · Received April 14, 2010

    Report

    Report Number
    2954323-2010-00493
    Event Type
    Injury
    Date Received
    April 14, 2010
    Date of Event
    March 14, 2010
    Report Date
    April 14, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO OF THE DEVICES WERE RECEIVED ON 03/26/2010 AND THE INVESTIGATION RESULTS ARE AS FOLLOWS: METER (B) (4) WAS RETURNED AND AN INVESTIGATION UTILIZING THE RETURNED METER, RETAINED TEST STRIPS (LOT NO: 1002834) AND RETAINED CONTROL SOLUTION (LOT NO: 9F3P10) HAS DETERMINED THE COMPLAINT IS NOT CONFIRMED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. DATE OF MANUFACTURE: (B) (4) IS 06/27/2007 METER (B) (4) WAS RETURNED AND AN INVESTIGATION UTILIZING THE RETURNED METER, RETAINED TEST STRIPS (LOT NO: 1002834) AND RETAINED CONTROL SOLUTION (LOT NO: 9F3P11) HAS DETERMINED THE COMPLAINT IS NOT CONFIRMED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. DATE OF MANUFACTURE: (B) (4) IS 08/11/2007. THE OTHER METER, (B) (4) HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FINAL REPORT FOR THAT METER WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON (B) (6) 2010 SHE ATTEMPTED TO TEST USING HER THREE FREESTYLE LITE BLOOD GLUCOSE METERS, (SERIAL NOS: (B) (4), (B) (4) AND (B) (4)), BUT NOTED THE TEST DID NOT START AFTER A BLOOD SAMPLE WAS APPLIED TO A TEST STRIP INSERTED, SEQUENTIALLY, INTO THEM. IT WAS FURTHER REPORTED THAT DURING A PHONE CONVERSATION WITH HER DAUGHTER, HER DAUGHTER REALIZED THAT SOMETHING WAS WRONG BECAUSE HER MOTHER WAS SLURRING HER WORDS. IT WAS AT THIS POINT THE CUSTOMER THEN LOST CONSCIOUSNESS. PARAMEDICS WERE CALLED, RECEIVED A READING, ON AN UNKNOWN BRAND OF METER, OF 26 MG/DL AND ADMINISTERED DEXTROSE VIA AN INTRAVENOUS INFUSION. AFTER CUSTOMER REGAINED CONSCIOUSNESS, SHE SELF-TREATED WITH FOOD. CUSTOMER CHOSE NOT TO BE TRANSFERRED TO A LOCAL HEALTHCARE FACILITY. 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 LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1002834

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention