BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1799821 · Received August 13, 2010

    Report

    Report Number
    2954323-2010-01117
    Event Type
    Injury
    Date Received
    August 13, 2010
    Date of Event
    July 24, 2010
    Report Date
    August 13, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS IDENTIFIED THAT THE CUSTOMER WAS REPORTEDLY ATTEMPTING TO USE INCOMPATIBLE TEST STRIPS WITH HER BLOOD GLUCOSE METER. ADC CUSTOMER SERVICE EDUCATED THE CALLER ABOUT TEST STRIP COMPATIBILITY. THIS CASE DOES NOT INVOLVE A PRODUCT MALFUNCTION AND NO PRODUCT INVESTIGATION IS REQUIRED. THIS IS THE FINAL REPORT. NOTE: CUSTOMER'S DAUGHTER REPORTED CUSTOMER WAS USING INCOMPATIBLE FREESTYLE CLASSIC TEST STRIPS (LOT# 1000437) WITH THEIR FREESTYLE FREEDOM LITE METER ((B)(4)).

    Description of Event or Problem · 1

    CUSTOMER'S FAMILY MEMBER REPORTED CUSTOMER'S FREESTYLE FREEDOM LITE METER DID NOT TURN ON WITH TEST STRIP INSERTION. CUSTOMER'S FAMILY MEMBER FURTHER REPORTED CUSTOMER EXPERIENCED SYMPTOMS OF SWEATINESS, UNRESPONSIVENESS AND LOSS OF CONSCIOUSNESS. PARAMEDICS WERE CALLED AND TRANSPORTED CUSTOMER TO A HEALTH CARE FACILITY. IT IS UNKNOWN IF THERE WAS ANY DIAGNOSIS OR TREATMENT GIVEN AT THE HEALTH CARE FACILITY. CUSTOMER'S FAMILY MEMBER ALSO REPORTED CUSTOMER TOOK HER INSULIN MEDICATION; HOWEVER, IT IS UNCLEAR IF IT WAS TAKEN BEFORE OR AFTER THE REPORTED EVENT. ADC CUSTOMER SERVICES MADE MULTIPLE ATTEMPTS TO FOLLOW-UP WITH THE CUSTOMER FOR ADDITIONAL INFORMATION BUT WITHOUT ANY SUCCESS. 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 LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1000437

    Patients

    Seq Age Sex Outcome Treatment
    1 Other