BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24758061 · Received April 1, 2026

    Report

    Report Number
    3016798778-2026-00077
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    February 26, 2026
    Report Date
    April 1, 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 THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM. THE CURRENT VERSION OF THE TWIIST AID 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 02-MAR-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 03-MAR-2026. THE USER'S CAREGIVER REPORTED THAT THE TWIIST CASSETTE AND CLEO 90 INFUSION SET TUBING AND SITE WERE CHANGED THE EVENING OF (B)(6) 2026. THE FOLLOWING MORNING, THE USER DEVELOPED LARGE KETONES AND VOMITING. GLUCOSE VALUES WERE NOT PROVIDED. THE USER'S CAREGIVER REPORTED THAT THERE WERE SMALL AIR BUBBLES OBSERVED WITHIN THE BLADDER OF THE TWIIST CASSETTE BUT DENIED THE PRESENCE OF AIR ALONG THE INFUSION SET TUBING, AND NO PUMP ALARMS WERE REPORTED. DESPITE AN ATTEMPTED BOLUS VIA THE PUMP AND INCREASED FLUIDS, THE USER WAS ADMITTED TO THE HOSPITAL FOR OVERNIGHT TREATMENT OF DIABETIC KETOACIDOSIS (DKA) WITH INTRAVENOUS (IV) FLUIDS AND EXOGENOUS INSULIN. THE USER RESUMED THERAPY ON THEIR TWIIST PUMP PRIOR TO DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820011 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 10 YR Female Other| H