BEUDAMED
    FDA Adverse Event Death Summary report: N

    H TRON INSULIN PUMP

    MDR report key: 549756 · Received July 22, 2004

    Report

    Report Number
    MW1032747
    Event Type
    Death
    Date Received
    July 22, 2004
    Date of Event
    January 15, 2003
    Report Date
    July 22, 2004
    Manufacturer
    DISETRONICS
    Product Code
    LZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER WAS DRIVING ALONE AND EXPERIENCED A LOW BLOOD SUGAR EPISODE. UNABLE TO CONTROL CAR AND WAS IN A FATAL ACCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H TRON INSULIN PUMP INSULIN PUMP LZG DISETRONICS V100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death