BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25237304 · Received May 20, 2026

    Report

    Report Number
    3016798778-2026-00137
    Event Type
    Injury
    Date Received
    May 20, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 20, 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

    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 REGARDING SYSTEM 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 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 20-APR-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE USER REPORTED THAT ON (B)(6) 2026, THEY CHANGED THEIR TWIST CASSETTE AND INFUSION SET AND BOLUSED FOR BREAKFAST "AS USUAL." AROUND NOON, THE USER NOTICED THAT THEIR GLUCOSE HAD INCREASED TO 400 MG/DL BUT THEY DID NOT TAKE ANY ACTION. THE USER REPORTED THAT DURING THE EVENING, THEY DID NOT EAT BUT BOLUSED THREE TIMES; HOWEVER, THEIR GLUCOSE REMAINED ELEVATED. BY 0100 ON (B)(6) 2026, THE USER BEGAN VOMITING BLOOD AND HAD SMALL KETONES. THE USER WAS ADMITTED TO THE HOSPITAL WHERE THEY WERE DIAGNOSED WITH DIABETIC KETOACIDOCIS AND CRITICAL KIDNEY INJURY. THE HOSPITAL STAFF REMOVED THE TWIST PUMP AND PLACED THE USER ON LANTUS AND HUMALOG INSULIN. THE USER DENIED RECEIVING ANY ALARMS FROM THE TWIIST PUMP AND STATED THAT IT HAD "TURNED OFF" AND LOOP WAS INACTIVE FOR SOME TIME. THE USER REPORTED THAT ON (B)(6) 2026, THEY ATTEMPTED TO USE THEIR TWIIST PUMP WITH A NEW CASSETTE AND INFUSION SET, BUT EXPERIENCED ELEVATED GLUCOSE LEVELS IN THE 400S MG/DL. THE USER ELECTED TO DISCONTINUE USE OF THE TWIIST SYSTEM AND PLANNED TO BE DISCHARGED ON MULTIPLE DAILY INJECTIONS (MDI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500232 TWIIST AUTOMATED INSULIN DELIVERY SYSTEM INFUSION PUMP QFG MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-21073-007 00850017421400

    Patients

    Seq Age Sex Outcome Treatment
    1