BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24631393 · Received March 18, 2026

    Report

    Report Number
    3016798778-2026-00059
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    February 16, 2026
    Report Date
    March 18, 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 REPORTED EVENT CANNOT BE CONFIRMED. THE 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 BECAUSE THE USER CHANGED THEIR CLEO 90 INFUSION SITE TO ATTEMPT TO ADDRESS THEIR ELEVATED BLOOD GLUCOSE. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP. THE 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, AT THIS TIME.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 16-FEB-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON THE SAME DAY. THE USER REPORTED A FINGERSTICK BLOOD GLUCOSE VALUE OVER 600 MG/DL AFTER EXCHANGING THE TWIIST CASSETTE AND CLEO 90 INFUSION SET. THE USER DID NOT CHECK FOR KETONES AND DID NOT REQUIRE EMERGENCY SERVICES. THE USER REPORTED CHANGING THEIR CLEO 90 INFUSION SITE TO TRY TO RESOLVE THE REPORTED EVENT. THE USER REMAINS ONGOING ON THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694228 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Other