BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 2173942 · Received July 24, 2011

    Report

    Report Number
    2954323-2011-03923
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 30, 2011
    Report Date
    September 30, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING.

    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 AVAILABLE.

    Additional Manufacturer Narrative · 1

    AS PRODUCT WAS NOT RETURNED, A DHR OF THE METER WAS REQUESTED. THE DEVICE HISTORY REVIEW FOR METER (B)(4) INDICATED THE DEVICE WAS PERFORMING WITHIN ITS PERFORMANCE CLAIMS AND MET THE MANUFACTURER'S QUALITY SPECIFICATIONS PRIOR TO ITS RELEASE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED HIGHER THAN FEELS READINGS ON HIS FREESTYLE FREEDOM METER. THE CUSTOMER REPORTED HE WAS IN THE AIRPORT IN THE (B)(6) 2011 AROUND 8 OR 9 PM WHEN HE OBTAINED A READING OF "80 OR 88" MG/DL ON HIS FREESTYLE METER. THE CUSTOMER REPORTED HE "FELT LOW AND PASSED OUT." THE CUSTOMER REPORTED HE EXPERIENCED A LOSS OF CONSCIOUSNESS AND A SEIZURE, IN ADDITION TO SYMPTOMS OF CONFUSION AND PANIC. PARAMEDICS WERE SUMMONED AND ADMINISTERED AN INJECTION OF GLUCOSE TO THE CUSTOMER. THE CUSTOMER ALSO REPORTED SELF-TREATMENT WITH GLUCOSE TABLETS AND A SANDWICH. THERE IS 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 BLOOD GLUCOSE MONITORING SYSTEM NBW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R