BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST SEQUEL

    MDR report key: 24666385 · Received March 23, 2026

    Report

    Report Number
    MW5185607
    Event Type
    Injury
    Date Received
    March 23, 2026
    Report Date
    March 15, 2026
    Manufacturer
    DEKA RESEARCH & DEVELOPMENT CORP.
    Product Code
    QFG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE TWIIST PUMP BY SEQUEL DOES NOT PROVIDE SUBSTANTIAL ALERTS FOR HYPERGLYCEMIC EVENTS NOR DOES IT WORK ACTIVELY ENOUGH TO COUNTERACT HYPERGLYCEMIC EVENTS, LEADING TO OVERALL WORSE BLOOD SUGARS, WHICH LEAD TO HIGHER RISK OF ORGAN FAILURE, NEUROPATHY, ETC. THE TWIIST TEAM IS FAIRLY RESPONSIVE BUT OFFERS NO SOLUTION NO DO THEY ACKNOWLEDGE THAT THE ISSUE WILL LEAD TO WORSENED HEALTH RESULTS. OVER THE PAST SEVERAL MONTHS, I HAVE EXPERIENCED THE WORST HYPERGLYCEMIC EVENTS SINCE I WAS FIRST DIAGNOSED WITH TYPE 1 DIABETES. THERE ARE NO SECONDARY ALERTS TO HIGH BLOOD SUGARS, THE ALERTS YOU DO RECEIVE DO NOT UPDATE SO YOU'LL SEE THE SAME NUMBER EACH TIME EVEN IF THE NUMBER HAS CHANGED DRASTICALLY, AND THE "CLOSED LOOP SYSTEM" FUNCTIONALLY DOES NOT WORK HARD ENOUGH TO CORRECT HYPERGLYCEMIC EVENTS, CAUSING THEM TO LAST HOURS AT A TIME DESPITE MANUALLY CORRECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732608 TWIIST SEQUEL ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG DEKA RESEARCH & DEVELOPMENT CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Life Threatening NOVOLOG.