BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1823108 · Received September 1, 2010

    Report

    Report Number
    2954323-2010-01212
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    August 11, 2010
    Report Date
    September 1, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT. THIS CASE INVOLVES TRAINING ISSUES AND DOES NOT INVOLVE A PRODUCT MALFUNCTION. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER REQUESTED TRAINING ON HOW TO CODE HER FREESTYLE LITE METER. ADC CUSTOMER SERVICES REFERRED CUSTOMER TO APPROPRIATED PAGES IN USERS GUIDE FOR ASSISTANCE AND EDUCATED CUSTOMER ABOUT NON-CODED METER. CUSTOMER REPORTED EXPERIENCING SYMPTOMS OF HEADACHE, VOMITING AND DIARRHEA. CUSTOMER ALSO REPORTED GOING TO A HEALTH CARE FACILITY WHERE SHE WAS DIAGNOSED WITH SEVERE HYPERGLYCEMIA AND TREATED WITH INSULIN AND AN IV. CUSTOMER FURTHER REPORTED SHE WAS HOSPITALIZED FOR 3 DAYS. 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 LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1014210

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R