BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24769696 · Received April 2, 2026

    Report

    Report Number
    3016798778-2026-00078
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    February 27, 2026
    Report Date
    April 2, 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 CURRENT VERSION OF THE TWIIST AID SYSTEM USER GUIDE PROVIDES INFORMATION ABOUT PREVENTING HYPERGLYCEMIA. THIS GUIDE EXPLAINS THAT THE LINE BLOCKED ALARM IS TRIGGERED WHEN INSULIN IS BLOCKED FROM BEING DELIVERED DUE TO A KINK IN THE INFUSION SET TUBING OR INFUSION SITE. THE USER GUIDE ALSO INSTRUCTS USERS TO ALWAYS HAVE A BACKUP INSULIN THERAPY PLAN READY. THE CLEO 90 INFUSION SET IS DISTRIBUTED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR USE WITH THE TWIIST AID SYSTEM. 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 04-MAR-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON THE SAME DAY. ON (B)(6) 2026, THE USER CHANGED THEIR CLEO 90 INFUSION SET AND DELIVERED A BOLUS. THE USER REPORTED STOPPING THE BOLUS MID-DELIVERY BECAUSE THEY BELIEVED THAT THE SYSTEM HAD RECOMMENDED TOO MUCH INSULIN. THE USER THEN WENT TO WORK, ATE LUNCH, AND DELIVERED ADDITIONAL BOLUSES, AT WHICH POINT THE USER NOTICED THAT THEIR GLUCOSE WAS NOT RESPONDING AND WAS IN THE 235-250 MG/DL RANGE. THE USER CHANGED THEIR INFUSION SITE TWICE AND DELIVERED ADDITIONAL BOLUSES WITHOUT RESOLUTION OF THEIR ELEVATED GLUCOSE. THE USER REPORTED THAT THEY WERE USING A NEW VIAL OF INSULIN. LINE BLOCKED ALARMS WERE ALSO REPORTED; HOWEVER, THE USER CONFIRMED THAT INSULIN WAS COMING OUT OF THE END OF THE INFUSION SET TUBING, AS EXPECTED. AT 9PM, THE USER'S GLUCOSE WAS 450 MG/DL. THE USER REPORTED THAT A FINGERSTICK LATER CONFIRMED A BLOOD GLUCOSE OF 603 MG/DL. THE USER CHANGED THEIR INFUSION SITE A THIRD TIME AND DELIVERED A BOLUS, OPTING TO PRESENT TO THE EMERGENCY ROOM ON (B)(6) 2026 AT 5AM. THE USER WAS ADMINISTERED INTRAVENOUS (IV) FLUIDS AND WAS SUBSEQUENTLY TRANSFERRED TO THE INTENSIVE CARE UNIT FOR IV INSULIN TO TREAT DIABETIC KETOACIDOSIS. THE USER WAS HOSPITALIZED FOR TWO DAYS AND DISCHARGED ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832401 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007; DKPI-11073-001 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Hospitalization| O