BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24394023 · Received February 19, 2026

    Report

    Report Number
    3016798778-2026-00031
    Event Type
    Injury
    Date Received
    February 19, 2026
    Date of Event
    January 20, 2026
    Report Date
    May 29, 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

    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, SYSTEM FUNCTIONALITY CANNOT BE VERIFIED AT THIS TIME. HOWEVER, THIS EVENT IS NOT BEING REPORTED TO THE FDA AS A DEVICE MALFUNCTION AS THE USER REMAINS ONGOING ON THEIR TWIIST PUMP AND EXCHANGED THEIR INFUSION SITE TO ADDRESS THEIR ELEVATED GLUCOSE. ICU MEDICAL'S CLEO 90 INFUSION SET IS DISTRIBUTED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR USE WITH THE TWIIST AID 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 20-JAN-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED CHANGING THEIR INFUSION SITE EARLY IN THE MORNING ON (B)(6) 2026. THE USER REPORTED THAT THEY WERE UNSURE IF THE CLEO 90 INFUSION SITE WAS INSERTED CORRECTLY AS THEY DID NOT HEAR THE EXPECTED "CLICK" AND NOTICED THAT THE NEEDLE DID NOT IMMEDIATELY RETRACT UPON REMOVAL OF THE INSERTER FROM THEIR SKIN. UPON WAKING A FEW HOURS LATER, THE USER REPORTED A SENSOR GLUCOSE READING OF OVER 400 MG/DL. THE USER REPORTED SHORTNESS OF BREATH BUT DECLINED NEEDING EMERGENCY SERVICES. THE USER REPORTEDLY CHANGED THEIR INFUSION SITE AND ADMINISTERED EXOGENOUS INSULIN TO ADDRESS THEIR ELEVATED GLUCOSE. THE USER LATER REPORTED THAT THEY CONSISTENTLY EXPERIENCE POSTPRANDIAL HYPERGLYCEMIA USING THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM, NOTING THAT THEIR INFUSION SITES ARE OFTEN RED AND SWOLLEN. THE USER REMAINS ONGOING ON THE TWIIST AID SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247220 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1