BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 474656 · Received July 31, 2003

    Report

    Report Number
    2954323-2003-00083
    Event Type
    Injury
    Date Received
    July 31, 2003
    Date of Event
    July 4, 2003
    Report Date
    July 31, 2003
    Manufacturer
    THERASENSE, INC.
    Product Code
    LFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED PASSING OUT IN 2003. CUSTOMER'S FAMILY MEMBER THEN TESTED CUSTOMER THREE TIMES CONSECUTIVELY WITH THE FREESTYLE METER GETTING RESULTS OF 200, 196 AND 29 MG/DL. CUSTOMER REPORTED THAT AFTER FAMILY MEMBER RECEIVED THE THREE FREESTYLE READINGS, FAMILY MEMBER ADMINISTERED A "SUGAR SHOT" TO GET PT TO COME AROUND.

    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