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

Model Number	DKPI-11073-001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An initial event notification was received by sequel med tech, llc, on (b)(6) 2026 and forwarded to millyard advanced medical products, llc, on the same day.The user reported that the pigtail tubing detached from their twiist cassette when they rolled over in their sleep.The user changed their cassette and resumed therapy without issue.The user remains ongoing on their twiist pump.
Additional Manufacturer Narrative
Cassette (b)(4) was returned for investigation with the cassette pigtail tubing detached.Inspection of the cassette confirmed damage to the tubing, with evidence indicating that there was excessive pulling force that caused the tubing to stretch, fray, and break.The user remains ongoing on their twist pump.The twist automated insulin delivery system user guide instructs users to have a backup 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: 50180970
• Report Number: 3016798778-2026-00256
• Device Sequence Number: 8281712
• Product Code: QFG
• UDI-Device Identifier: 00850017421431
• UDI-Public: (01)00850017421431(17)261211
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: 07/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2025
• 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: 35 YR
• Patient Sex: Female
• Patient Weight: 123 LB
• Patient Race: White