BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25262569 · Received May 22, 2026

    Report

    Report Number
    3016798778-2026-00151
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    April 18, 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
    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

    PRELIMINARY ANALYSIS OF THE LOG DATA REVEALS OCCLUSION-LIKE BEHAVIOR LEADING UP TO EACH LINE BLOCKED ALARM WITHOUT ANY PUMP FUNCTIONALITY ISSUES. HOWEVER, INVESTIGATION INTO THE REPORTED EVENT 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 (AID) SYSTEM USER GUIDE PROVIDES INFORMATION ABOUT SYSTEM ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM, AS WELL AS WAYS TO PREVENT HYPERGLYCEMIA. USERS ARE ALSO INSTRUCTED 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. 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 23-APR-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED PERSISTENT LINE BLOCKED ALARMS AND PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2026 WITH ELEVATED GLUCOSE LEVELS. THE USER WAS TREATED WITH INTRAVENOUS FLUIDS AND AN INSULIN INJECTION BEFORE BEING RELEASED. THE USER REPORTED PERFORMING MULTIPLE TROUBLESHOOTING STEPS, INCLUDING CHANGING THE TWIIST CASSETTE, CLEO 90 INFUSION SET, AND INFUSION SITE MULTIPLE TIMES; HOWEVER, THE LINE BLOCKED ALARMS CONTINUED. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361622 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