BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1894417 · Received November 9, 2010

    Report

    Report Number
    2954323-2010-01537
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 13, 2010
    Report Date
    November 9, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING INVESTIGATION OF THE DELIVERY ISSUE, IT WAS IDENTIFIED THAT THE ADDRESS PROVIDED BY THE CUSTOMER WAS INCORRECT. A SUCCESSFUL FIELD EXCHANGE WAS PROVIDED FOR THE CUSTOMER DURING THE CALL. AS THIS INCIDENT INVOLVED A DELIVERY DELAY, NO DEVICE IS EXPECTED BACK FOR INVESTIGATION. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    AN ADC CUSTOMER'S FAMILY MEMBER REPORTED THAT DUE TO A DELIVERY DELAY IN RECEIVING THEIR ADC FS LITE METER AND TEST STRIPS THE CUSTOMER'S CERTIFIED NURSING ASSISTANT FOUND HER "UNRESPONSIVE" AND APPARENTLY CUSTOMER HAD LOST CONSCIOUSNESS WHILE AT HOME AT 5PM ON THE DATE OF THE EVENT. PARAMEDICS WERE CALLED AND IT IS REPORTED CUSTOMER WAS TREATED ON SCENE WITH "IV GLUCAGON". CUSTOMER WAS TRANSPORTED TO A HEALTH CARE FACILITY, DIAGNOSED WITH HYPOGLYCEMIA AND TREATED WITH ADDITIONAL "IV GLUCAGON". 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 LITE BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 Other