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	05/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 instucts users to have a backup insulin therapy available at all times.No product has been returned and no additional information relevant to the reported event has been made available to millyard advanced medical products, llc, at this time.
Event or Problem Description
An initial event notification was received by sequel med tech, llc, on 12-may-2026 and forwarded to millyard advanced medical products, llc on the same day.The user reported that the pigtail tubing detached from the body of the twiist cassette while they were asleep.

• 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: 25479343
• Report Number: 3016798778-2026-00185
• Device Sequence Number: 5445354
• Product Code: QFG
• UDI-Device Identifier: 00850017421431
• UDI-Public: (01)00850017421431
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2026

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
• Device Lot Number: MM900053002073
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2026
• Supplement Report FDA Received Date: 08/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2026
• 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: 29 YR
• Patient Sex: Female