BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 23923549 · Received December 30, 2025

    Report

    Report Number
    3016798778-2025-00150
    Event Type
    Injury
    Date Received
    December 30, 2025
    Date of Event
    December 1, 2025
    Report Date
    January 16, 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

    A SPECIFIC CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT. NO MATERIAL WAS RETURNED FOR INVESTIGATION AND NO LOG FILES ARE AVAILABLE FROM THE TIMEFRAME OF THE COMPLAINT; THEREFORE, THE LINE BLOCKED ALARM COULD NOT BE CONFIRMED AND SYSTEM FUNCTIONALITY COULD NOT BE VERIFIED. HOWEVER, THIS EVENT IS NOT BEING REPORTED TO THE FDA AS A DEVICE MALFUNCTION BECAUSE 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 WAS REPORTED THAT THE USER SUCCESSFULLY RESOLVED THE LINE BLOCKED ALARM BY REPLACING THE INFUSION SITE, INDICATING THAT THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM ALERTED THE USER APPROPRIATELY. THE INFUSION SET IS DISTRIBUTED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR USE WITH THE TWIIST AID SYSTEM. ALTHOUGH NO SYSTEM ISSUE WAS IDENTIFIED, THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION BECAUSE THE USER SOUGHT MEDICAL ATTENTION AFTER ADMINISTERING EXOGENOUS INSULIN FOLLOWING A LINE BLOCKED ALARM. NO COMPONENTS OR ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR FURTHER INVESTIGATION. THE CURRENT VERSION OF THE TWIIST AID SYSTEM USER GUIDE PROVIDES INFORMATION ABOUT SYSTEM ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM. THIS GUIDE WARNS, "DO NOT TAKE EXTERNAL INSULIN, SUCH AS MANUAL INSULIN INJECTIONS OR INHALED INSULINS, WHILE LOOP IS ON AND THE TWIIST PUMP IS OPERATIONAL. THE TWIIST AID SYSTEM DOES NOT RECEIVE INFORMATION ABOUT INSULIN TAKEN OUTSIDE THE SYSTEM. IF YOU CHOOSE TO TAKE ADDITIONAL INSULIN WITH ANOTHER METHOD WHILE LOOP IS ON AND THE TWIIST PUMP IS WORKING, OVER-DELIVERY OR UNDER-DELIVERY OF INSULIN MAY OCCUR, WHICH CAN LEAD TO HIGH AND LOW GLUCOSE."

    Additional Manufacturer Narrative · 0

    THE ADDITIONAL INFORMATION AVAILABLE FOR ASSESSMENT INDICATES THAT THE LINE BLOCKED ALARMS TRIGGERED BY THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM ARE CONSISTENT WITH THE REPORT OF MULTIPLE KINKED INFUSION SET CANNULAS. HOWEVER, NO MATERIAL WAS RETURNED FOR INVESTIGATION AND NO LOG FILES ARE AVAILABLE FROM THE TIMEFRAME OF THE COMPLAINT; THEREFORE, THE LINE BLOCKED ALARMS COULD NOT BE CONFIRMED AND SYSTEM FUNCTIONALITY COULD NOT BE VERIFIED. THE USER SUCCESSFULLY RESOLVED THE LINE BLOCKED ALARMS BY REPLACING THE INFUSION SET, INDICATING THAT THE TWIIST AID SYSTEM ALERTED THE USER APPROPRIATELY. THE 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. THE CURRENT VERSION OF THE TWIIST AID SYSTEM USER GUIDE PROVIDES INFORMATION ABOUT SYSTEM ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM. THIS GUIDE EXPLAINS THAT 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. THE USER GUIDE ALSO WARNS, "DO NOT TAKE EXTERNAL INSULIN, SUCH AS MANUAL INSULIN INJECTIONS OR INHALED INSULINS, WHILE LOOP IS ON AND THE TWIIST PUMP IS OPERATIONAL. THE TWIIST AID SYSTEM DOES NOT RECEIVE INFORMATION ABOUT INSULIN TAKEN OUTSIDE THE SYSTEM. IF YOU CHOOSE TO TAKE ADDITIONAL INSULIN WITH ANOTHER METHOD WHILE LOOP IS ON AND THE TWIIST PUMP IS WORKING, OVER-DELIVERY OR UNDER-DELIVERY OF INSULIN MAY OCCUR, WHICH CAN LEAD TO HIGH AND LOW GLUCOSE."

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY (B)(6), LLC, ON 02-DEC-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED HAVING A LINE BLOCKED ALARM THAT THEY BELIEVE RESULTED IN A GLUCOSE VALUE OF 300 MG/DL. THE USER CHANGED THEIR INFUSION SITE AND ADMINISTERED 13 UNITS OF EXOGENOUS INSULIN WHILE DRINKING HOT COCOA. THE USER'S GLUCOSE SUBSEQUENTLY DECREASED TO 32 MG/DL AND THE USER BECAME UNRESPONSIVE. EMERGENCY MEDICAL SERVICES WERE CALLED AND THE USER REGAINED CONSCIOUSNESS AFTER DEXTROSE WAS ADMINISTERED INTRAVENOUSLY. THE USER WAS NOT TRANSPORTED TO THE HOSPITAL.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 02-DEC-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. CLARIFICATION REGARDING A SERIES OF EVENTS INITIALLY BELIEVED TO BE UNRELATED TO MDR 3016798778-2025-00150 WAS PROVIDED BY SEQUEL MED TECH, LLC, ON 02-JAN-2025 AT THE REQUEST OF MILLYARD ADVANCED MEDICAL PRODUCTS, LLC. THE USER REPORTED THAT AN INFUSION SET PLACED ON (B)(6) 2025 FELL OFF AFTER 8 HOURS OF WEAR. THE USER PLACED A SECOND INFUSION SET, WHICH RESULTED IN A LINE BLOCKED ALARM DUE TO THE CANNULA OF THE INFUSION SET BEING KINKED. THE USER THEN PLACED A THIRD INFUSION SET IN A DIFFERENT SITE BUT RECEIVED ANOTHER LINE BLOCKED ALARM. THE USER PLACED A FOURTH INFUSION SET IN A NEW SITE BUT REPORTED HAVING A LINE BLOCKED ALARM AND A GLUCOSE VALUE OF 300 MG/DL. THE USER REPORTED THAT THE CANNULA OF THE INFUSION SET WAS AGAIN KINKED. THE USER ADMINISTERED 13 UNITS OF EXOGENOUS INSULIN WHILE DRINKING HOT COCOA; HOWEVER, THE USER'S GLUCOSE SUBSEQUENTLY DECREASED TO 32 MG/DL AND THE USER BECAME UNRESPONSIVE. EMERGENCY MEDICAL SERVICES (EMS) WERE CALLED AND THE USER REGAINED CONSCIOUSNESS AFTER DEXTROSE WAS ADMINISTERED INTRAVENOUSLY. THE USER WAS NOT TRANSPORTED TO THE HOSPITAL. AFTER RECOVERING, THE USER PLACED A FIFTH INFUSION SET IN A DIFFERENT SITE AND BLOOD WAS SEEN IMMEDIATELY UPON APPLICATION. THE USER LATER REPORTED A GLUCOSE VALUE AROUND 400 MG/DL THAT DID NOT REQUIRE EMS. UPON REMOVAL OF THE SITE, THE INFUSION SET CANNULA WAS FOUND TO BE KINKED. THE USER CHANGED THE INFUSION SET AND THEIR GLUCOSE DECREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2272965 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Other| R