BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 467690 · Received June 24, 2003

    Report

    Report Number
    2954323-2003-00067
    Event Type
    Injury
    Date Received
    June 24, 2003
    Report Date
    June 24, 2003
    Manufacturer
    THERASENSE, INC.
    Product Code
    LFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN JUNE 2003 CUSTOMER REPORTED TESTING WITH THE FREESTYLE METER GETTING RESULTS BETWEEN 130-140 MG/DL. CUSTOMER WAS EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA AND WAS UNCONSCIOUS. CUSTOMER'S SPOUSE ADMINSTERED GLUCAGON AND A GLASS OF JUICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM LFR THERASENSE, INC. NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention MEDICATION NOT REPORTED.| CALLER TAKES A STRONG PRESCRIBED ASPIRIN. NAME OF