BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24215708 · Received January 29, 2026

    Report

    Report Number
    3016798778-2026-00016
    Event Type
    Injury
    Date Received
    January 29, 2026
    Date of Event
    December 31, 2025
    Report Date
    February 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 CORRELATION BETWEEN THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM AND THE USER'S SYMPTOMS COULD NOT BE CONFIRMED. AT THIS TIME, THE REPORTED LINE BLOCKED ALARMS 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 ALARMS BY REPLACING THE CASSETTE, INFUSION SET TUBING, AND INFUSION SITE, SHIFTING THE SITE TO THE OPPOSITE SIDE OF THEIR ABDOMEN. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP. 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.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT, A CORRELATION BETWEEN THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM AND THE REPORTED SYMPTOMS COULD NOT BE CONFIRMED. DUE TO THE LACK OF RETURNED PRODUCT AND ELECTRONIC LOG DATA, SYSTEM PERFORMANCE COULD NOT BE VERIFIED AND THE REPORTED LINE BLOCKED ALARMS COULD NOT BE CONFIRMED. THE CASSETTE WAS ADDED TO SECTION D4 AND THE APPLICABLE CODES WERE MODIFIED IN SECTION H6. 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 ALARMS BY REPLACING THE CASSETTE, INFUSION SET TUBING, AND INFUSION SITE, AS WELL AS SHIFTING THE SITE TO THE OPPOSITE SIDE OF THEIR ABDOMEN. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP. 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 31-DEC-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. ON (B)(6) 2025, THE USER REPORTED NAUSEA AND VOMITING, WITH A BLOOD GLUCOSE OF 400 MG/DL AT 09:00. THE USER ALSO REPORTED RECEIVING MULTIPLE LINE BLOCKED ALARMS THAT WERE RESOLVED BY CHANGING THE CASSETTE, INFUSION SET TUBING, AND INFUSION SITE, SHIFTING THE SITE TO THE OPPOSITE SIDE OF THEIR ABDOMEN. THE USER REPORTED THAT THEY DID NOT HAVE ANY BACKUP SUPPLIES TO ADMINISTER A MANUAL INJECTION WITH A SYRINGE OR INSULIN PEN AND DECIDED TO GO THE EMERGENCY ROOM FOR TREATMENT. THE USER WAS ADMITTED TO THE HOSPITAL AND TREATED WITH INSULIN INJECTIONS. THE USER WAS ULTIMATELY DISCHARGED ON (B)(6) 2026. THE USER REMAINS ONGOING ON THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278569 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 22 YR Female Hospitalization| O