BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2072289 · Received April 28, 2011

    Report

    Report Number
    2954323-2011-03092
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 19, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED ON RETURNED METER (B)(4) WITH RETAINED TEST STRIPS. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL FUNCTIONAL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. A SIMILAR READING WAS FOUND IN METER MEMORY.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING AN ER-3 MESSAGE ON THEIR FREESTYLE FREEDOM LITE METER ON (B)(6) 11 AT 10:00 OR 10:30 PM AND ALSO MENTIONED A READING OF 200 MG/DL. THE CUSTOMER REPORTEDLY FELT TIRED AND "COULD NOT REMEMBER WHAT HAPPEN AFTER THAT." THE CUSTOMER FURTHER REPORTED LOSING CONSCIOUSNESS AND BEING TREATED BY PARAMEDICS WITH GLUCOSE INTRAVENOUS INFUSION ON THE SCENE. THE CUSTOMER WAS NOT TRANSPORTED TO A HEALTH CARE FACILITY AND IN ADDITION SELF-TREATED WITH "EXTRA STRENGTH PAIN RELEASE GEL PILL, AND MAYBE A ADVIL" WITH FOOD TO COUNTERACT THE EVENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1102106

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R