BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-TRONPLUS

    MDR report key: 583617 · Received March 9, 2005

    Report

    Report Number
    2183996-2005-00120
    Event Type
    Malfunction
    Date Received
    March 9, 2005
    Date of Event
    January 7, 2005
    Report Date
    February 7, 2005
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS INC
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE (200 - 550 MG/DL), FOR THE PAST MONTH. ADDITIONALLY, PATIENT REPORTED THAT 2 INSULIN CARTRIDGES HAD LEAKED INSIDE OF THE DEVICE'S CARTRIDGE CHAMBER. PATIENT STATED THAT THEY BELIEVE THE DEVICE IS NOT DELIVERING THE PROPER AMOUNT OF INSULIN. NO ERROR MESSAGES WERE GENERATED BY THE DEVICE. PATIENT SELF-TREATED ELEVATED BLOOD GLUCOSE BY DELIVERING ADDITIONAL INSULIN, VIA BOLUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-TRONPLUS INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS INC D-TRONPLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR INSULIN, INSULIN INFUSION SET, DATE OF TRETMENT