BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25262606 · Received May 22, 2026

    Report

    Report Number
    3016798778-2026-00150
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    April 2, 2026
    Report Date
    May 22, 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

    INVESTIGATION INTO THE REPORTED EVENT REMAINS ONGOING AND A SUPPLEMENTAL REPORT WILL BE FILED ONCE RESULTS ARE AVAILABLE. THE CURRENT VERSION OF THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM USER GUIDE PROVIDES INFORMATION ABOUT THE LINE BLOCKED ALARM AND THE CUSTOMIZATION OF ALARMS AND SYSTEM SOUNDS. THIS GUIDE ALSO PROVIDES WAYS TO PREVENT HYPERGLYCEMIA AND INSTRUCTS USERS TO HAVE A BACKUP INSULIN THERAPY AVAILABLE AT ALL TIMES. THE CLEO 90 INFUSION SET IS DISTRIBUTED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR USE WITH THE TWIIST AID SYSTEM. ATTEMPTS TO FOLLOW UP WITH THE USER HAVE BEEN UNSUCCESSFUL. NO ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT HAS 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 22-APR-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER WAS ADMITTED TO THE HOSPITAL WITH DIABETIC KETOACIDOSIS (DKA) ON (B)(6) 2026, FOLLOWING APPROXIMATELY THREE DAYS OF USE ON THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM. THE USER WAS DISCHARGED ON MULTIPLE DAILY INJECTIONS. DURING THEIR THREE DAYS OF PUMP USE, THE USER REPORTEDLY SUSPENDED THE TWIIST AID SYSTEM MULTIPLE TIMES FOR EXTENDED PERIODS DUE TO FEAR OF HYPOGLYCEMIA. ON THE THIRD NIGHT, THE USER EXPERIENCED TWO LINE BLOCKED ALARMS WHILE SLEEPING AND DID NOT WAKE TO RESPOND TO THE ALARMS WHICH PAUSED INSULIN DELIVERY, PER DESIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67924 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1