BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24339182 · Received February 13, 2026

    Report

    Report Number
    3016798778-2026-00026
    Event Type
    Injury
    Date Received
    February 13, 2026
    Date of Event
    January 16, 2026
    Report Date
    April 9, 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 WITH THE INFORMATION AVAILABLE FOR ASSESSMENT. NO MATERIAL WAS RETURNED AND SYSTEM LOG DATA FROM THE TIME OF THE EVENT IS UNAVAILABLE FOR REVIEW; THEREFORE, SYSTEM FUNCTIONALITY CANNOT BE VERIFIED. HOWEVER, THIS EVENT IS NOT BEING REPORTED TO THE FDA AS A DEVICE MALFUNCTION AS THE USER REPORTED A BENT INFUSION SITE CANNULA, AS WELL AS TUBING THAT WAS PULLED OUT OF THEIR NEW INFUSION SITE, AS THE LIKELY CAUSE OF THEIR ELEVATED GLUCOSE AND SUBSEQUENT SYMPTOMS. ICU MEDICAL'S CLEO 90 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.

    Additional Manufacturer Narrative · 0

    A SPECIFIC CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE FOR ASSESSMENT. NO MATERIAL WAS RETURNED AND INVESTIGATION INTO THE EVENT REMAINS 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 REPORTED A BENT INFUSION SITE CANNULA, AS WELL AS TUBING THAT WAS PULLED OUT OF THEIR NEW INFUSION SITE, AS THE LIKELY CAUSE OF THEIR ELEVATED GLUCOSE AND SUBSEQUENT SYMPTOMS. 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 (B)(6) 2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED A SENSOR GLUCOSE VALUE OF 400 MG/DL ACCOMPANIED BY VOMITING. THE USER REMOVED THE CLEO 90 INFUSION SITE AND OBSERVED THAT THE CANNULA WAS BENT. WHILE ATTEMPTING TO APPLY A NEW INFUSION SITE, THE USER REPORTEDLY PULLED THE INFUSION SET TUBING OUT. THE USER SWITCHED TO ANOTHER MANUFACTURER'S INSULIN PUMP AND DID NOT REQUIRE EMERGENCY SERVICES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1