BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25262600 · Received May 22, 2026

    Report

    Report Number
    3016798778-2026-00145
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    April 19, 2026
    Report Date
    May 22, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QFG
    UDI-DI
    00850017421400
    PMA / PMN Number
    K250930
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THE REPORTED EVENT 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 INFUSION SITE ROTATION, AS WELL AS WAYS TO PREVENT HYPERGLYCEMIA. 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 AID SYSTEM. NO ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT HAS 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 22-APR-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED BEING ADMITTED TO THE HOSPITAL FOR DIABETIC KETOACIDOSIS (DKA). THE USER REPORTED A ROUTINE SUPPLY CHANGE ON (B)(6) 2026, PLACING THE CLEO 90 INFUSION SITE ON THEIR ABDOMEN. SEVERAL HOURS LATER, THE USER'S CONTINUOUS GLUCOSE MONITOR (CGM) READINGS INCREASED TO >400 MG/DL. THE USER REPORTED BOLUSING VIA THE TWIIST PUMP WITHOUT RESOLUTION AND ADMINISTERING EXTERNAL FAST-ACTING INSULIN, WHICH TEMPORARILY REDUCED GLUCOSE TO THE 150S MG/DL, BEFORE VALUES ROSE AGAIN BY BEDTIME. THE MORNING OF (B)(6) 2026, CGM READINGS WERE AGAIN >400 MG/DL AND THE USER REPORTED VOMITING AND LARGE KETONES, PROMPTING THEM TO PRESENT TO THE HOSPITAL. FINGERSTICK GLUCOSE AT THAT TIME WAS 530 MG/DL. THE USER REPORTED THAT THE TWIIST PUMP WAS REMOVED IN THE HOSPITAL AND INTRAVENOUS INSULIN WAS ADMINISTERED. THE EVENING OF (B)(6) 2026, THE USER ATTEMPTED TO RESUME PUMP THERAPY WITH A CASSETTE CHANGE BUT WITHOUT CHANGING THE ABDOMINAL INFUSION SITE. AFTER A MEAL BOLUS, GLUCOSE REPORTEDLY INCREASED INTO THE 400S MG/DL, LEADING HOSPITAL STAFF TO DISCONTINUE THE TWIIST PUMP AGAIN AND RESUME LONG- AND FAST-ACTING INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205096 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1