BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2143492 · Received June 29, 2011

    Report

    Report Number
    2954323-2011-03707
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 28, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THE MEDICAL EVENT WAS RELATED TO CUSTOMER USING INCOMPATIBLE TEST STRIPS, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. THEREFORE, NO FURTHER INVESTIGATION OF THE PRODUCT IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER'S DAUGHTER REPORTED THAT THE CUSTOMER"S ADC BLOOD GLUCOSE MONITOR TURNS ON WITH BUTTON PRESSED BUT DOES NOT TURN ON UPON TEST STRIP INSERTION. THE CUSTOMER WAS USING AN INCOMPATIBLE TEST STRIPS. CUSTOMER FURTHER REPORTED SUBSEQUENTLY EXPERIENCED PALENESS, FEET AND LEGS WERE HURTING, LIGHTHEADEDNESS, DIZZINESS, "NOT AS ACTIVE", LOST OF APPETITE, AND LOST CONSCIOUSNESS. THE CUSTOMER WAS SEEN BY THE DOCTOR AND WAS DIAGNOSED WITH HYPOGLYCEMIA. THE CUSTOMER WAS TREATED WITH INSULIN AND GLUCOSE PILLS. THE CUSTOMER DENIED SELF-TREATMENT. 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 NBW 082202

    Patients

    Seq Age Sex Outcome Treatment
    1 Other