BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25247040 · Received May 21, 2026

    Report

    Report Number
    3016798778-2026-00141
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 21, 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

    INVESTIGATION INTO THE REPORTED EVENT REMAINS ONGOING AND A SUPPLEMENTAL REPORT WILL BE FILED ONCE RESULTS ARE AVAILABLE. THE CURRENT VERSION OF THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM USER GUIDE PROVIDES INFORMATION REGARDING SYSTEM ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM, INCLUDING PUMP ERROR ALARMS, AS WELL AS WAYS TO PREVENT HYPERGLYCEMIA. USERS ARE ALSO INSTRUCTED TO HAVE A BACKUP INSULIN THERAPY AVAILABLE AT ALL TIMES. 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 21-APR-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED THAT DESPITE TROUBLESHOOTING EFFORTS, THEY RECEIVED REPEATED PUMP ERROR ALARMS WHICH RESULTED IN AN INTERRUPTION IN INSULIN DELIVERY. THE USER FURTHER REPORTED THAT THEIR GLUCOSE WAS ELEVATED, WITH A FINGERSTICK VALUE OF 470 MG/DL, AND THEY EXPERIENCED A BIT OF NAUSEA. THE USER TREATED THE ELEVATED GLUCOSE WITH MANUAL INJECTIONS AS THEY WERE UNABLE TO BOLUS VIA THE TWIIST PUMP, AND DENIED NEEDING EMERGENCY MEDICAL SERVICES. THE USER CONFIRMED THEY WOULD CONTINUE USING THEIR BACKUP INSULIN THERAPY WHILE AWAITING A REPLACEMENT PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194996 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1