BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2152864 · Received July 7, 2011

    Report

    Report Number
    2954323-2011-03787
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 17, 2011
    Report Date
    August 23, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVEL BECAUSE HER ADC BLOOD GLUCOSE METER TURNS OFF RIGHT AFTER THE SAMPLE WAS APPLIED. CUSTOMER FURTHER REPORTED SUBSEQUENTLY EXPERIENCED OF "BOTTOMED OUT", LOST CONSCIOUSNESS, AND BEING UNRESPONSIVE. CUSTOMER WAS TREATED WITH AN UNSPECIFIED MEDICATION INTRAVENOUSLY AND WITH FOOD IN A HEALTH CARE FACILITY. CUSTOMER SELF-TREATED BY EATING FOOD AND DRINKING JUICE. 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 1162010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention