BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1884345 · Received October 27, 2010

    Report

    Report Number
    2954323-2010-01488
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 27, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT INVESTIGATION IS REQUIRED. THE CALLER ADMITTED THAT THE METER PORT WAS CONTAMINATED WITH BLOOD. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER'S DAUGHTER REPORTED THE CUSTOMER INSERTED THE WRONG END OF THE TEST STRIP INTO THE PORT OF HER FREESTYLE FREEDOM BLOOD GLUCOSE METER, AND ALSO THAT THE PORT WAS CONTAMINATED WITH BLOOD. THE CUSTOMER WAS REPORTEDLY UNABLE TO TEST AND MEDICATE HERSELF PROPERLY AND AS A RESULT, SHE EXPERIENCED A MEDICAL EVENT WHEN SHE FELT WEAK. IT IS UNKNOWN IF THE CUSTOMER LOST CONSCIOUSNESS OR HAD SEIZURE. THE PARAMEDICS WERE CALLED AND THE CUSTOMER WAS REPORTEDLY TREATED WITH A "GLUCOSE INJECTION" AND INTRAVENOUS FLUIDS. ALTHOUGH IT WAS REPORTED THE CUSTOMER WAS TRANSPORTED TO A HEALTH CARE FACILITY, NO FURTHER INFORMATION ABOUT THE EVENT IS AVAILABLE BECAUSE THE CUSTOMER'S DAUGHTER REFUSED TO COMPLETE THE MEDICAL TROUBLESHOOTING SURVEY. 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 BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention