BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25049993 · Received April 30, 2026

    Report

    Report Number
    3016798778-2026-00109
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 30, 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 ROOT CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE FOR ASSESSMENT. THE INVESTIGATION REMAINS ONGOING AND A SUPPLEMENTAL REPORT WILL BE FILED ONCE RESULTS ARE AVAILABLE. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP. THE CURRENT VERSION OF THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM USER GUIDE PROVIDES INFORMATION ABOUT ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM, INCLUDING THE CGM HIGH GLUCOSE ALERT, AS WELL AS WAYS TO PREVENT HYPERGLYCEMIA. THIS GUIDE EXPLAINS THAT THE TWIIST AID SYSTEM IS COMPATIBLE WITH FAST-ACTING U-100 HUMALOG (INSULIN LISPRO) AND NOVOLOG (INSULIN ASPART). USERS ARE ALSO INSTRUCTED TO HAVE A BACKUP INSULIN THERAPY AVAILABLE AT ALL TIMES. THE CLEO 90 INFUSION SET IS DISTRIBUTED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR USE WITH THE TWIIST AUTOMATED INSULIN DELIVERY SYSTEM. AT THIS TIME, NO COMPONENTS OR ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR FURTHER ANALYSIS.

    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. BETWEEN (B)(6) 2026, THE USER EXPERIENCED HYPERGLYCEMIA WHILE USING THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM WITH FIASP INSULIN. ON (B)(6) 2026, THE USER REPORTED A GLUCOSE VALUE OF 350 MG/DL FOLLOWING A SCHEDULED CLEO 90 INFUSION SET AND TWIIST CASSETTE CHANGE. THE USER REMOVED THE TWIIST PUMP AND ADMINISTERED 10 UNITS OF INSULIN VIA A PEN. GLUCOSE IMPROVED TO 203 MG/DL. THE USER LATER CHANGED THEIR CLEO 90 INFUSION SITE AND RESUMED THERAPY USING THE TWIIST AID SYSTEM. ON (B)(6) 2026, THE USER REPORTED SEEING A CONTINUOUS GLUCOSE MONITOR (CGM) VALUE OF "HIGH" (>400 MG/DL), REPORTING A GLUCOSE RANGE OF 349-403 MG/DL. DESPITE CHANGING THE CLEO 90 INFUSION SET AND TWIIST CASSETTE, THE USER DEVELOPED NAUSEA AND EXPRESSED CONCERN REGARDING POTENTIAL DIABETIC KETOACIDOSIS. THE USER WAS DRIVEN TO THE EMERGENCY ROOM (ER) AND THEIR GLUCOSE WAS FOUND TO BE APPROXIMATELY 350 MG/DL. THEY WERE TESTED FOR KETONES (RESULTS NOT DISCLOSED), WERE ADMINISTERED 10 UNITS OF INSULIN, AND WERE NOT ADMITTED. THE PUMP REMAINED ON DURING THE ER VISIT. THE USER STABILIZED WITH GLUCOSE IN THE 100S MG/DL AND REPORTED THE TWIIST AID SYSTEM HAS FUNCTIONED WELL SINCE THE EVENT. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399185 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Other