BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREE STYLE

    MDR report key: 369170 · Received January 2, 2002

    Report

    Report Number
    2954323-2001-00056
    Event Type
    Injury
    Date Received
    January 2, 2002
    Date of Event
    November 28, 2001
    Report Date
    December 21, 2001
    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

    CALLER'S SPOUSE EXPERIENCED DEEP HYPOGLYCEMIA DURING THE NIGHT THAT LED TO A LIMITED CONVULSIVE STATE. HIGHLY SUGARED LIQUID (COCA-COLA) WAS GIVEN AND HONEY APPLIED TO GUMS. WITHIN 20 MINUTES PATIENT RECOVERED AND ATE SOME BREAD. CONSECUTIVE RESULTS FROM THE FREE STYLE WERE 150 MG/DL / 150 MG/. A SECOND SET OF CONSECUTIVE TESTS PRODUCED BLOOD GLUCOSE RESULTS OF 240 MG/DL AND 100 MG/DL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention