BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 3232945 · Received July 18, 2013

    Report

    Report Number
    2954323-2013-00386
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 20, 2013
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER WAS RETURNED AND TESTED WITH RETAINED TEST STRIPS. 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 COMPLAINT OF 'TEST DOES NOT START' WAS NOT OBSERVED DURING PRODUCT INVESTIGATION. NOTE: THE REPORTED MEDICAL EVENT IS RELATED TO TWO ADDITIONAL METERS (CEGR312-M3678 AND CEGR187-M1522) AND REPORTED IN TWO ADDITIONAL MDRS.

    Description of Event or Problem · 1

    CALLER (CUSTOMER'S WIFE) REPORTED THAT FOR APPROXIMATELY FIVE WEEKS THE CUSTOMER WAS UNABLE TO TEST USING HIS THREE ADC BLOOD GLUCOSE METERS DUE TO THE TESTS NOT STARTING AFTER THE BLOOD SAMPLES WERE APPLIED. CALLER FURTHER REPORTED THE CUSTOMER HAD AN APPOINTMENT AT THE VA HOSPITAL AT 10:00AM ON (B)(6) 2013 AND HAD HIS BLOOD GLUCOSE CHECKED. CUSTOMER RECEIVED A CALL FROM THE VA HOSPITAL AT APPROXIMATELY 5:00PM AND IT WAS STATED "HIS BLOOD SUGAR (WAS) AT 564 MG/DL (OBTAINED ON UNSPECIFIED HCP METER) AND HIS KETONES (WERE) ALSO HIGH". CUSTOMER WAS TAKEN TO THE EMERGENCY ROOM, TREATED WITH AN UNSPECIFIED INTRAVENOUS TREATMENT AND A GLASS OF WATER, AND WAS REPORTEDLY "NOT RESPONSIVE TO THE INSTRUCTION". CALLER FURTHER REPORTED THE CUSTOMER EXPERIENCED UNSPECIFIED SYMPTOMS AND DENIED SELF-TREATMENT. AN ADDITIONAL READING OF 461 MG/DL WAS OBTAINED WHILE CUSTOMER WAS IN THE EMERGENCY ROOM AND IT WAS UNKNOWN BY THE CALLER WHAT, IF ANY, DIAGNOSIS WAS RECEIVED BY THE CUSTOMER. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333987 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1352835

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R