BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-TRONPLUS

    MDR report key: 817383 · Received November 9, 2004

    Report

    Report Number
    2183996-2004-00849
    Event Type
    Malfunction
    Date Received
    November 9, 2004
    Date of Event
    October 12, 2004
    Report Date
    October 15, 2004
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED THAT SHE IS EXPERIENCING ELEVATED BLOOD GLUCOSE (200 MG/DL, NORMALLY 150 - 155 MG/DL). PATIENT PROGRAMMED A 5U BOLUS, WHILE DISCONNECTED, AND NO INSULIN CAME OUT. SHE PROGRAMMED AN ADDITIONAL 3U BOLUS, AND OBSERVED "ONE SMALL DROP" OF INSULIN. NO ERROR MESSAGES WERE GENERATED BY THE DEVICE. NO TREATMENT WAS RECEIVED FOR ELEVATED BLOOD GLUCOSE.

    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 YR INSULIN| INSULIN INFUSION SET