BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1973102 · Received January 28, 2011

    Report

    Report Number
    2954323-2011-01256
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 25, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER WAS RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. BATTERY WAS REPLACED AND METER FUNCTIONED PROPERLY. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER CALLED IN REQUESTING METER SETUP TRAINING AND REPORTED THE TEST DOESN'T START AFTER SAMPLE IS APPLIED. THE CUSTOMER FURTHER REPORTED DUE TO LACK OF TESTING AND DELAY OF TREATMENT, SHE EXPERIENCED LIGHTHEADEDNESS, NAUSEA AND TREMULOUSNESS WITH A SUBSEQUENT LOSS OF CONSCIOUSNESS. THE CUSTOMER REPORTEDLY SELF-TREATED WITH TYLENOL. NO THIRD-PARTY MEDICAL INTERVENTION WAS REPORTED. 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 1025815

    Patients

    Seq Age Sex Outcome Treatment
    1 Other