BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24840767 · Received April 10, 2026

    Report

    Report Number
    3016798778-2026-00092
    Event Type
    Malfunction
    Date Received
    April 10, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 10, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QFG
    UDI-DI
    00850017421400
    PMA / PMN Number
    K250930
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT, A RELATIONSHIP BETWEEN THE TWIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE INVESTIGATION IS ONGOING, AND A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE CURRENT VERSION OF THE TWIST AID SYSTEM USER GUIDE PROVIDES INFORMATION ABOUT SYSTEM ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM, AS WELL AS HOW TO PREVENT HYPERGLYCEMIA. THIS GUIDE ALSO INSTRUCTS USERS TO ALWAYS HAVE A BACKUP INSULIN THERAPY PLAN READY. NO COMPONENTS OR ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, AT THIS TIME.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 19-MAR-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED BEING IN THE INTENSIVE CARE UNIT (ICU) WITH DIABETIC KETOACIDOSIS (DKA) ATTRIBUTED TO A MALFUNCTION OF THE TWIIST PUMP (SERIAL NUMBER: (B)(6). THE USER REMAINS ONGOING ON THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620021 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Other| H