MAUDE Adverse Event Report: Millyard Advanced Medical Products, LLC twiist Automated Insulin Delivery System; Infusion Pump

Model Number	DKPI-11073-001
Medical Device Problem Codes	Leak/Splash (1354); Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the user received a pump error alarm from their twiist automated insulin delivery (aid) system that they were unable to resolve.Upon removing the cassette, the user's caregiver observed moisture inside the pump and stated that it smelled like insulin.The user reverted to their backup insulin therapy while awaiting a replacement twiist pump.
Additional Manufacturer Narrative
Cassette (b)(6) was returned and verified to be in use at the time of the event.During investigation testing, a cassette leak was confirmed.Upon disassembly, a deformation of the measurement valve edge was confirmed, consistent with the observed leakage.The deformation was determined to be associated with a manufacturing process.The contract manufacturer was notified of the investigation findings and will continue to monitor the issue.Upon disassembly of returned twiist pump, serial number (b)(6), fluid ingress was confirmed.The observed ingress was consistent with the leak identified in the returned cassette, as well as the reported pump error alarm.--- 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.Users are also instructed to have a backup insulin therapy available at all times.No additional information relevant to the reported event has been made available to millyard advanced medical products, llc, for further investigation.

• Brand Name: twiist Automated Insulin Delivery System
• Common Device Name: Infusion Pump
• Manufacturer (Section D): Millyard Advanced Medical Products, LLC; 540 n. commercial st.; suite 306; manchester NH 03101
• Manufacturer (Section G): Millyard Advanced Medical Products, LLC; 540 n. commercial st.; suite 306; manchester NH 03101
• Manufacturer Contact: victoria maroon ; 540 n. commercial st.; suite 306; manchester, NH 03101 ; +1(603)206-0591
• MDR Report Key: 50601164
• Report Number: 3016798778-2026-00421
• Device Sequence Number: 18819182
• Product Code: QFG
• UDI-Device Identifier: 00850017421431
• UDI-Public: (01)00850017421431(17)261209
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K250930
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DKPI-11073-001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 294 LB