BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24643418 · Received March 19, 2026

    Report

    Report Number
    3016798778-2026-00062
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    February 16, 2026
    Report Date
    March 19, 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

    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. INVESTIGATION INTO THE REPORTED EVENT REMAINS ONGOING AND A FOLLOW-UP MDR WILL BE FILED ONCE RESULTS ARE OBTAINED. NO COMPONENTS OR ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, AT THIS TIME. THE TWIIST AID SYSTEM USER GUIDE PROVIDES INFORMATION ABOUT SYSTEM ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM, INCLUDING THE LINE BLOCKED ALARM. THIS GUIDE ALSO PROVIDES INFORMATION ABOUT ADDRESSING ELEVATED BLOOD GLUCOSE AND INSTRUCTS USERS TO ALWAYS HAVE A BACKUP INSULIN THERAPY PLAN READY. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON (B)(6) 2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, THAT SAME DAY. THE USER REPORTED RECEIVING LINE BLOCKED ALARMS ON (B)(6) 2026 AND CHANGING THEIR CLEO 90 INFUSION SITE TO RESOLVE THE ALARMS. THE USER THEN EXPERIENCED ELEVATED BLOOD GLUCOSE AND RECEIVED A HIGH GLUCOSE ALERT. THE USER ADMINISTERED MULTIPLE BOLUSES VIA THE TWIIST PUMP, BUT THEIR GLUCOSE REMAINED ELEVATED. THE USER THEN ADMINISTERED EXOGENOUS INSULIN, AND THEIR GLUCOSE DECREASED AS EXPECTED. THE USER LATER REPORTED THAT THEIR GLUCOSE BEGAN TO INCREASE ONCE AGAIN, PROMPTING THEM TO CHANGE THEIR CLEO 90 INFUSION SITE AND TUBING, AS WELL AS THE TWIIST CASSETTE. UPON REMOVAL, THE USER REPORTED THAT PUSHING DOWN ON THE VALVE PARTS OF THE TWIIST CASSETTE DREW BUBBLES INTO THE CASSETTE AND DID NOT PUSH INSULIN THROUGH THE INFUSION SET TUBING. THE USER IS ONGOING ON THEIR TWIIST PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703598 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 37 YR Male Other