BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1951673 · Received January 6, 2011

    Report

    Report Number
    2954323-2011-00091
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 9, 2010
    Report Date
    February 4, 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. ALL FUNCTIONAL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READINGS THE CUSTOMER REPORTED WERE FOUND IN METER MEMORY. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE RESULTS OF THE READINGS WERE PLOTTED ON A PARKES ERROR GRID AND FELL INTO THE "A" ZONE SHOWING THE DIFFERENCE IN VALUES WAS NOT CLINICALLY SIGNIFICANT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT ON (B)(6) 2010, HE RECEIVED WITHIN TEN MINUTES THE FOLLOWING READINGS ON HIS FREESTYLE FREEDOM LITE BLOOD GLUCOSE METER: 258 MG/DL AND 228 MG/DL. THE CUSTOMER ADDITIONALLY REPORTED THAT DUE THE READINGS WHICH HE DESCRIBED AS "NOT ACCCURATE", HE SELF-ADMINISTERED "TOO MUCH INSULIN" AND THEN FELT SHAKY. THE CUSTOMER ALSO REPORTED HE PASSED OUT, COULD NOT GET UP AND YELLED FOR HELP. NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED AND NO DIABETES MEDICATIONS WERE REPORTEDLY TAKEN TO COUNTERACT THE EVENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1012038

    Patients

    Seq Age Sex Outcome Treatment
    1 Other