BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24705831 · Received March 26, 2026

    Report

    Report Number
    3016798778-2026-00066
    Event Type
    Injury
    Date Received
    March 26, 2026
    Date of Event
    February 24, 2026
    Report Date
    March 26, 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 SPECIFIC ROOT CAUSE FOR THE REPORTED LINE BLOCKED ALARMS CANNOT BE CONFIRMED. THE LINE BLOCKED ALARM IS IN PLACE TO ALERT THE USER THAT INSULIN IS BLOCKED FROM BEING DELIVERED, WHICH MAY OCCUR DUE TO A KINK IN THE INFUSION SET TUBING OR AT THE INFUSION SITE. IT IS UNKNOWN HOW THE LINE BLOCKED ALARM WAS ULTIMATELY RESOLVED; HOWEVER, IT WAS REPORTED THAT THE USER'S BODY HABITUS LIMITS THE NUMBER OF VIABLE INFUSION SITES. INVESTIGATION REMAINS ONGOING AND A SUPPLEMENTAL REPORT WILL BE FILED ONCE RESULTS ARE AVAILABLE. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP. THE CURRENT VERSION OF THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM USER GUIDE PROVIDES INFORMATION ABOUT SYSTEM ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM. THIS GUIDE ALSO INSTRUCTS USERS TO CONTACT SEQUEL CUSTOMER SUPPORT TO REPORT UNEXPECTED OPERATION OR EVENTS. 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, FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 24-FEB-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER'S CAREGIVER REPORTED A LINE BLOCKED ALARM STARTING AT 11:36 AM. DESPITE TROUBLESHOOTING EFFORTS, INCLUDING CHECKING FOR KINKS AND REPLACING THE CLEO 90 INFUSION SET, THE ALARM COULD NOT BE RESOLVED. CONSEQUENTLY, INSULIN DELIVERY WAS SUSPENDED FOR APPROXIMATELY 4 HOURS, DURING WHICH THE USER'S BLOOD GLUCOSE INCREASED TO 450 MG/DL AND THE USER EXPERIENCED DIAPHORESIS. THE USER'S CAREGIVER ADMINISTERED EXOGENOUS INSULIN VIA AN INSULIN PEN. THE CAREGIVER NOTED THAT THE USER HAS A "VERY LEAN" BODY HABITUS AND IS LIMITED TO A SINGLE INFUSION SITE LOCATION FOR THE CLEO 90 INFUSION SET. THE USER REMAINS ONGOING ON THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767288 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 8 YR Male Other