BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIIST AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24502580 · Received March 3, 2026

    Report

    Report Number
    3016798778-2026-00042
    Event Type
    Injury
    Date Received
    March 3, 2026
    Date of Event
    February 1, 2026
    Report Date
    March 3, 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

    BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT, A CORRELATION BETWEEN THE TWIIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM AND THE USER'S SYMPTOMS COULD NOT BE CONFIRMED. HOWEVER, THIS EVENT IS NOT BEING REPORTED TO THE FDA AS A DEVICE MALFUNCTION BECAUSE THE LINE BLOCKED ALARM IS IN PLACE TO ALERT THE USER THAT INSULIN IS BLOCKED FROM BEING DELIVERED, WHICH MAY OCCUR DUE TO A KINK IN THE INFUSION SET TUBING OR AT THE INFUSION SITE. REVIEW OF THE USER'S AVAILABLE COMPLAINT HISTORY IDENTIFIED A PRIOR EVENT IN WHICH THE USER REPORTED INTENTIONALLY SUSPENDING INSULIN DELIVERY VIA THE TWIIST PUMP FOR AN UNRELATED REASON ON (B)(6) 2026, THE SAME DATE AS THE EVENT REPORTED IN THIS MEDICAL DEVICE REPORT (MDR). DURING THAT TIME, THE USER REPORTED GLUCOSE VALUES UP TO 401 MG/DL. THREE ATTEMPTS WERE MADE BY SEQUEL MED TECH, LLC TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS WERE PROVIDED. BASED ON THE INFORMATION AVAILABLE, A RELATIONSHIP BETWEEN THE REPORTED HYPERGLYCEMIA DURING THE INTENTIONAL SUSPENSION OF THE TWIIST PUMP AND THE EVENT DESCRIBED IN THIS MDR COULD NOT BE ESTABLISHED. 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 AID SYSTEM. NO COMPONENTS OR ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC, ON 02-FEB-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 04-FEB-2026. THE USER REPORTED THAT ON (B)(6) 2026, THEY HAD A LINE BLOCKED ALARM THAT THEY RESOLVED USING THEIR EXISTING TWIIST CASSETTE.THE USER THEN ADMINISTERED MULTIPLE BOLUSES BUT STARTED TO FEEL "TERRIBLE." THE USER WENT TO THE EMERGENCY ROOM (ER) WITH A GLUCOSE VALUE OF 632 MG/DL, AND WAS TREATED WITH FLUIDS AND INSULIN. THE USER WAS IN THE ER FOR APPROXIMATELY 4-5 HOURS BEFORE BEING SENT HOME. THE USER REPORTED THAT DIABETIC KETOACIDOSIS WAS NOT CONFIRMED AS THERE WERE ISSUES WITH THE HOSPITAL'S TEST. THE USER ALSO REPORTED THAT THEY CHANGE THEIR TWIIST CASSETTE EVERY 3 DAYS, BUT OFTEN LEAVE THEIR CLEO 90 INFUSION SITE IN FOR "5 DAYS OR SO," AND TEND TO GET LINE BLOCKED ALARMS OFTEN. ADDITIONALLY, THE USER ENDORSED NOT ROTATING THEIR INFUSION SITE LOCATION ADEQUATELY AND REPORTED THAT THEY CAN FEEL BUMPS UNDER THEIR SKIN. THE USER ALSO REPORTED BEING CHRONICALLY DRY AND NOT DRINKING ENOUGH FLUIDS DURING THE DAY. THE USER REMAINS ONGOING ON THE TWIIST AUTOMATED INSULIND DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24912 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 40 YR Female Other