BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24593065 · Received March 13, 2026

    Report

    Report Number
    3016798778-2026-00054
    Event Type
    Injury
    Date Received
    March 13, 2026
    Date of Event
    February 4, 2026
    Report Date
    March 13, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QFG
    UDI-DI
    00850017421400
    PMA / PMN Number
    K250930
    Adverse Event
    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 TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM AND THE USER'S SYMPTOMS COULD NOT BE CONFIRMED. THE INVESTIGATION IS ONGOING, AND A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP. 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 17-FEB-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 18-FEB-2026. THE USER BEGAN USING THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM ON (B)(6) 2026. ON, (B)(6) 2026, THE USER PRESENTED TO THE EMERGENCY ROOM WITH HYPERGLYCEMIA AND VOMITING. USE OF THE TWIIST AID SYSTEM WAS DISCONTINUED IN THE HOSPITAL, AND THE USER WAS ADMITTED FOR TWO NIGHTS. AS OF ON (B)(6) 2026, THE USER REMAINS ONGOING ON THE TWIIST AID SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652606 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Hospitalization