BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1880431 · Received October 22, 2010

    Report

    Report Number
    2954323-2010-01468
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 22, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER SERIAL # (B)(4) WAS RETURNED FOR AN INVESTIGATION. THE COMPLAINT WAS NOT CONFIRMED. THE METER POWERED ON WITH THE BUTTON AND INSERTION OF TEST STRIP (RETAINED LOT # 1001525). THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED HIS FREESTYLE FREEDOM BLOOD GLUCOSE METER WOULD TURN ON WITH THE BUTTON, BUT NOT WHEN A TEST STRIP WAS INSERTED INTO THE PORT. THE CUSTOMER ADDITIONALLY REPORTED HE LOST CONSCIOUSNESS DUE TO THIS ISSUE. THE PARAMEDICS WERE CALLED AND THE CUSTOMER REPORTED THEY TESTED HIS BLOOD GLUCOSE LEVEL (READING IS UNKNOWN) AND GAVE HIM A "SHOT" OF GLUCOSE. THE CUSTOMER WAS NOT REPORTEDLY TRANSPORTED TO A HEALTH CARE FACILITY. IN ADDITION, THE CUSTOMER REPORTED HE TOOK HIS INSULIN AND THIS WAS NOT A CHANGE TO HIS NORMAL MEDICATION. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM NBW 1000832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other