BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2012448 · Received March 9, 2011

    Report

    Report Number
    2954323-2011-02142
    Event Type
    Injury
    Date Received
    March 9, 2011
    Date of Event
    February 7, 2011
    Report Date
    April 20, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION WAS PERFORMED ON RETURNED METER (B)(4) AND TEST STRIPS LOT NUMBER 1014141. 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 NOT 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 HE OBTAINED AN UNSPECIFIED READING ON HIS FREESTYLE FREEDOM LITE METER THAT WAS HIGHER THAN HE FELT AND SELF-DOSED WITH INSULIN OFF OF THAT READING, WHICH RESULTED IN A HYPOGLYCEMIC EPISODE WITH SUBSEQUENT LOSS OF CONSCIOUSNESS. THE CUSTOMER FURTHER REPORTED BEING SEEN AT A HEALTH CARE FACILITY AND REFUSED TO PROVIDE ANY ADDITIONAL INFORMATION. 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 1014141

    Patients

    Seq Age Sex Outcome Treatment
    1 Other