BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24096753 · Received January 16, 2026

    Report

    Report Number
    3016798778-2026-00006
    Event Type
    Injury
    Date Received
    January 16, 2026
    Date of Event
    December 16, 2025
    Report Date
    January 16, 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

    A SPECIFIC CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT. SYSTEM LOGS FROM THE TIME OF THE EVENT ARE NOT AVAILABLE. THE INFUSION SET IS DISTRIBUTED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR USE WITH THE TWIIST AUTOMATED INSULIN DELIVERY 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 18-DEC-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED CHANGING THEIR INFUSION SITE AND CASSETTE ON (B)(6) 2025. UPON ATTEMPTING TO FILL THE NEW CASSETTE WITH INSULIN, THE USER REPORTED RESISTANCE WHEN INSERTING THE NEEDLE INTO THE CASSETTE'S FILLING PORT, STATING THAT THEY CONTINUOUSLY POKED UNTIL THE NEEDLE WENT THROUGH. THE USER WAS ABLE TO SUCCESSFULLY FILL THE CASSETTE; HOWEVER, A FEW HOURS LATER, THE USER REPORTED THAT THEIR BLOOD GLUCOSE BEGAN TO INCREASE. THE USER DENIED ANY INSULIN LEAKING FROM TWIIST CASSETTE OR PUMP. THE USER ALSO DENIED SMELLING INSULIN FROM THE EXTERIOR OF THE PUMP. THE USER WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025 WITH DIABETIC KETOACIDOSIS, REPORTING THAT THEIR BLOOD GLUCOSE WENT UP TO 474 MG/DL. THE USER REPORTED NOT HAVING THEIR SUPPLIES TO RETURN FOR INVESTIGATION. THE USER REMAINS ONGOING ON THE TWIIST PUMP (SERIAL NUMBER (B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164334 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Other| H