BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24435909 · Received February 24, 2026

    Report

    Report Number
    3016798778-2026-00036
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    January 25, 2026
    Report Date
    May 29, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QFG
    UDI-DI
    00850017421431
    PMA / PMN Number
    K250930
    Adverse Event
    Yes
    Product Problem
    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. INVESTIGATION IS ONGOING; THEREFORE, THE REPORTED CASSETTE EMPTY ALARMS CANNOT BE CONFIRMED AND SYSTEM FUNCTIONALITY CANNOT BE VERIFIED AT THIS TIME. THE CURRENT VERSION OF THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM USER GUIDE PROVIDES INFORMATION ABOUT SYSTEM ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM. THE RECOMMENDED ACTION FOR A CASSETTE EMPTY ALARM IS TO PERFORM A CASSETTE CHANGE. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP. EFFORTS TO OBTAIN ADDITIONAL INFORMATION ARE ONGOING. ANY NEW INFORMATION RELEVANT TO THE REPORTED EVENT WILL BE PROVIDED IN A FOLLOW UP REPORT. AT THE TIME OF THIS REPORT, 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 26-JAN-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED THAT AFTER CHANGING THEIR CASSETTE ON (B)(6) 2026, THEY RECEIVED MULTIPLE CASSETTE EMPTY ALARMS DESPITE INSULIN BEING IN THE CASSETTE. THE USER STATED THAT THE ALARMS CONTINUED THROUGH (B)(6) 2026 AND WERE TEMPORARILY RESOLVED BY REPLACING THE BATTERY IN THE PUMP. THE USER'S BLOOD GLUCOSE VALUE GOT UP TO 355 MG/DL AND THEY REPORTED EXPERIENCING SHORTNESS OF BREATH. THE USER DENIED OTHER SYMPTOMS AND DID NOT CHECK FOR KETONES. THE USER EXPRESSED CONCERN THAT THEY WERE NOT RECEIVING INSULIN DUE TO THE ALARMS BUT DECLINED ADDITIONAL TROUBLESHOOTING. THE USER WAS ADVISED TO REPLACE THEIR CASSETTE. THE USER REMAINS ONGOING ON THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50433 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11073-001 00850017421431

    Patients

    Seq Age Sex Outcome Treatment
    1