BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25165114 · Received May 13, 2026

    Report

    Report Number
    3016798778-2026-00127
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    April 11, 2026
    Report Date
    May 13, 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 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. USERS ARE ALSO INSTRUCTED TO HAVE A BACKUP INSULIN THERAPY AVAILABLE AT ALL TIMES. 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 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 13-APR-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED ONGOING HYPERGLYCEMIA BEGINNING ON (B)(6) 2026, WITH GLUCOSE VALUES RANGING FROM >300-400 MG/DL. PRIOR TO GOING TO SLEEP ON (B)(6) 2026, THE USER'S GLUCOSE WAS 466 MG/DL BY FINGERSTICK, AND THEY ADMINISTERED 5 UNITS OF INSULIN VIA INJECTION. AT APPROXIMATELY 0400 ON (B)(6) 2026, THE USER REPORTED NAUSEA AND SHORTNESS OF BREATH WITH A FINGERSTICK GLUCOSE OF 422 MG/DL. THE USER HAD MODERATE KETONES AND ADMINISTERED 10 UNITS OF INSULIN VIA INJECTION. UPON WAKING AT 0920, THE USER REPORTED HAVING A GLUCOSE OF 275 MG/DL. THE USER COMPLETED A FULL SUPPLY CHANGE (TWIIST CASSETTE AND CLEO 90 INFUSION SET) WITH A NEW INSULIN VIAL AND THEIR GLUCOSE DECREASED TO 211 MG/DL. THE USER REPORTED COMPLETING FOUR FULL SUPPLY CHANGES SINCE ON (B)(6) 2026 AND ROTATING INFUSION SITES (UPPER FRONT THIGHS LEFT/RIGHT/LEFT AND ABDOMEN). THE USER STATED THAT THE USED TWIIST CASSETTES AND CLEO 90 INFUSION SETS WERE DISCARDED AND ARE NOT AVAILABLE FOR RETURN. THE USER REMAINS ONGOING ON THEIR TWIIST PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419384 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007; DKPI-11073-001 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1