BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2022786 · Received March 17, 2011

    Report

    Report Number
    2954323-2011-02337
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 26, 2011
    Report Date
    March 17, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THIS REPORT INVOLVED A DELIVERY DELAY NO INVESTIGATION WILL BE PERFORMED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    AN ADC CUSTOMER REPORTED THAT AS A RESULT OF A DELIVERY DELAY IN REPLACEMENT TEST STRIPS FOR THEIR ADC METER THEY WERE UNABLE TO TEST AND EXPERIENCED FEELING LIGHT-HEADED AND DIZZY. THE CUSTOMER FURTHER REPORTED THAT AFTER EATING A CANDY BAR PARAMEDICS WERE CALLED. CUSTOMER WAS TREATED ON SCENE WITH INTRAVENOUS GLUCOSE AND TRANSPORTED TO A HEALTH CARE FACILITY. CUSTOMER WAS DIAGNOSED WITH HYPOGLYCEMIA AND FURTHER REPORTED BEING TREATED WITH INSULIN WHICH IS INCONSISTENT WITH THE DIAGNOSIS AND "SOMETHING FOR NAUSEA." NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention