BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24720363 · Received March 30, 2026

    Report

    Report Number
    3016798778-2026-00070
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    March 2, 2026
    Report Date
    May 29, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QFG
    UDI-DI
    00850017421431
    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 SYSTEM USER GUIDE PROVIDES INFORMATION ABOUT POTENTIAL CAUSES OF HYPERGLYCEMIA. THIS USER GUIDE ALSO INSTRUCTS USERS TO ALWAYS HAVE A BACKUP INSULIN THERAPY PLAN READY. 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 (B)(6) 2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER'S CAREGIVER REPORTED THAT THE USER EXPERIENCED ELEVATED BLOOD GLUCOSE VALUES AFTER CHANGING THEIR TWIIST CASSETTE AND CLEO 90 INFUSION SET, EATING DINNER, AND BOLUSING VIA THE TWIIST PUMP MULTIPLE TIMES ON (B)(6) 2026. AT 01:30 ON (B)(6) 2026, THE USER'S CAREGIVER REPORTED THAT THE INFUSION SITE WAS CHANGED AND ADDITIONAL BOLUSES WERE DELIVERED VIA THE TWIIST PUMP; HOWEVER, THE USER'S BLOOD GLUCOSE REACHED 558 MG/DL AND THEY BEGAN TO VOMIT. THE USER WAS ADMITTED TO THE EMERGENCY ROOM AND TREATED WITH INTRAVENOUS FLUIDS AND INSULIN. FOLLOWING DISCHARGE ON (B)(6) 2026, THE USER RESTARTED TWIIST THERAPY WITH A NEW CASSETTE, INFUSION SET, AND VIAL OF INSULIN. THE USER BOLUSED VIA THE TWIIST PUMP FOR DINNER THAT EVENING AND THE USER EXPERIENCED A RECURRENCE OF HYPERGLYCEMIA WITH A BLOOD GLUCOSE OF 527 MG/DL AND TRACE KETONES. A MANUAL INSULIN PEN INJECTION SUCCESSFULLY DECREASED THE USER'S BLOOD GLUCOSE TO 174 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37439 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11073-001 00850017421431

    Patients

    Seq Age Sex Outcome Treatment
    1