BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1811743 · Received August 23, 2010

    Report

    Report Number
    2954323-2010-01152
    Event Type
    Injury
    Date Received
    August 23, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 23, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER HAS BEEN RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED.

    Description of Event or Problem · 1

    A CUSTOMER IS A TYPE 1 DIABETES PATIENT AND USER OF AN INSULIN PUMP. THE CUSTOMER REPORTED HE WAS GETTING INACCURATELY HIGH READINGS ON HIS FREESTYLE FREEDOM LITE METER THAT RESULTED IN SEVERAL EPISODES OF HYPOGLYCEMIA WITH LOSS OF CONSCIOUSNESS. ON ONE OCCASION, THE CUSTOMER REPORTEDLY GOT A READING OF 130 MG/DL BEFORE GOING TO BED WHICH RESULTED IN A HYPOGLYCEMIC EPISODE WITH LOSS OF CONSCIOUSNESS. THE PARAMEDICS WERE CALLED AND TREATED CUSTOMER WITH GLUCAGON AND D50 INTRAVENOUSLY. THE CUSTOMER WAS FURTHER TRANSPORTED TO A LOCAL HOSPITAL WHERE HE WAS DIAGNOSED WITH HYPOGLYCEMIA AND FURTHER TREATED WITH INTRAVENOUS FLUIDS AND FOOD. 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 1008735

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R