BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1622516 · Received March 4, 2010

    Report

    Report Number
    2954323-2010-00249
    Event Type
    Injury
    Date Received
    March 4, 2010
    Date of Event
    February 11, 2010
    Report Date
    March 4, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THE DEVICE ((B) (4)) HAS BEEN RETURNED AND AN INVESTIGATION UTILIZING A NEW BATTERY, THE RETURNED METER, RETURNED TEST STRIPS (LOT NO: 0904936) AND RETAINED CONTROL SOLUTION (LOT NO: 9F3P11) HAS DETERMINED THE COMPLAINT IS NOT CONFIRMED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. IT SHOULD BE NOTED: IT IS UNKNOWN IF THE CUSTOMER WAS ATTEMPTING TO TEST USING HIS EXPIRED TEST STRIPS (LOT NO: 0704622, NOT RETURNED) OR THE TEST STRIPS (LOT NO: 0904936) WHICH WERE RETURNED WITH HIS METER, THAT ARE NOT EXPIRED.

    Description of Event or Problem · 1

    CUSTOMER CALLED CUSTOMER SERVICE ON (B) (6) 2010 TO REQUEST REPLACEMENT OF HIS EXPIRED TEST STRIPS. WHILE ON THE PHONE CUSTOMER REPORTED THAT BEGINNING APPROXIMATELY TWO WEEKS PRIOR TO THE CALL TO CUSTOMER SERVICE HIS FREESTYLE FREEDOM BLOOD GLUCOSE METER STARTED GIVING AN UNIDENTIFIED ERROR MESSAGE WHEN A TEST STRIP WAS INSERTED INTO THE METER. IT WAS FURTHER REPORTED THAT BECAUSE HE COULD NOT TEST HE EXPERIENCED "A LOW SUGAR EPISODE WHERE 'HE' COULD NOT SPEAK DUE TO LOSING CONSCIOUSNESS". CUSTOMER ALSO REPORTEDLY DESCRIBED THE EVENT AS A "MINI SEIZURE". IT WAS ADDITIONALLY REPORTED CUSTOMER'S WIFE WAS ABLE, WITH COAXING, TO GET CUSTOMER TO INGEST A SUGAR PASTE THAT CUSTOMER INCORRECTLY IDENTIFIED AS GLUCAGON (A PARENTERAL ANTIHYPOGLYCEMIC AGENT, NOT A PASTE). CUSTOMER ALSO SELF-TREATED AFTER BEING REVIVED BY EATING FOOD. 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 0704622

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention