BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2110671 · Received June 1, 2011

    Report

    Report Number
    2954323-2011-03452
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 8, 2011
    Report Date
    June 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. THE READING THE CUSTOMER REPORTED WAS FOUND IN METER MEMORY.

    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 REPORTED ON (B)(6) 2011 AT 5PM HE TOOK A BLOOD TEST WITH THEIR FREESTYLE FREEDOM LITE METER, RECEIVED A READING OF 112MG/DL AND THEN ATE FOOD. AROUND 6PM-6:30PM THE CUSTOMER EXPERIENCED WEAKNESS, DIAPHORESIS AND SUBSEQUENTLY LOST CONSCIOUSNESS. THE PARAMEDICS WERE CALLED AND UPON ARRIVAL RECEIVED "LO" MESSAGE ON THEIR METER OF UNKNOWN BRAND AND TREATED CUSTOMER WITH GLUCAGON. NO ADDITIONAL INFORMATION IS AVAILABLE AS THE CUSTOMER REFUSED TO COMPLETE TROUBLESHOOTING. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R