BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24082395 · Received January 15, 2026

    Report

    Report Number
    MW5182359
    Event Type
    Malfunction
    Date Received
    January 15, 2026
    Report Date
    January 9, 2026
    Manufacturer
    SEQUEL MED TECH / MILLYARD ADVANCED MEDICAL PRODUCTS LLC.
    Product Code
    QFG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A REPORTER CALLED TO SUBMIT A REPORT FOR TWIST AUTOMATED INSULIN PUMP MALFUNCTION. THE REPORTER SAID SHE WORKS FOR THE COMPANY AND SHE SAID THE PUMP HAS A DEFECTIVE CASSETTE WHICH LEAKS INSULIN INTO THE PUMP. SHE SAID IF THE INSULIN COMES IN CONTACT WITH ELECTRIC WIRE, IT FRIES THE PUMP AND SHE SAID THAT IS A SAFETY RISK IF IT HAPPENS IF THE PERSON IS ASLEEP. SHE SAID, SHE BROUGHT THIS ISSUE TO THE ATTENTION OF THE MANAGEMENT PEOPLE IN HER COMPANY BUT NOTHING HAS BEEN DONE. SHE SAID SHE IS AFRAID OF LOSING HER JOB BUT SHE DECIDED TO REPORT IT TO PROTECT THE USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139984 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG SEQUEL MED TECH / MILLYARD ADVANCED MEDICAL PRODUCTS LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female