BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1901881 · Received November 17, 2010

    Report

    Report Number
    2954323-2010-01570
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    October 26, 2010
    Report Date
    February 10, 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 CUSTOMER'S 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. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER'S SISTER CALLED CUSTOMER SERVICE ON OCTOBER 26, 2010 AND REPORTED, THE TEST DID NOT START ON CUSTOMER'S FREESTYLE FREEDOM BLOOD GLUCOSE METER AFTER A SAMPLE WAS APPLIED TO A TEST STRIP INSERTED INTO IT. SHE FURTHER REPORTED THAT BECAUSE THE METER WAS NOT GIVING HIM A READING, HE SUBSEQUENTLY EXPERIENCED A LOSS OF CONSCIOUSNESS. NO SYMPTOMS WERE REPORTEDLY EXPERIENCED PRIOR TO THE LOSS OF CONSCIOUSNESS. PARAMEDICS WERE CALLED AND PROVIDED GLUCOSE VIA AN INTRAVENOUS INFUSION. 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 BLOOD GLUCOSE MONITORING SYSTEM NBW 0915628

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R