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	Hyperglycemia (1905)
Date of Event	03/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An initial event notification was received by sequel med tech, llc, on 17-mar-2026 and forwarded to millyard advanced medical products, llc, on the same day.The user reported that during the night, the tubing had detached from their twiist cassette and they awoke with elevated glucose due to the event.The user reported a fingerstick value of 363 mg/dl and administered 12 units of insulin through a manual injection, following which, their glucose began trending downward.The user also stated that they would perform a cassette change.The user remains ongoing on their twiist pump.
Additional Manufacturer Narrative
Initial event information was received by sequel med tech, llc, on 17-mar-2026 and forwarded to millyard advanced medical products, llc, on the same day.Based on the information available at that time, the event was initially assessed as nonreportable.Product was later returned to millyard advanced medical products, llc, for investigation on 22-apr-2026 and a reportable malfunction was discovered by way of a technical investigation completed on 21-jul-2026.Therefore, for mdr purposes, the date received by the manufacturer (g3) is 21-jul-2026, and the report source (g2) is listed as company representative.--- cassette (b)(6) was returned for investigation with the cassette pigtail tubing detached.Further inspection revealed that the adhesive remained on the cassette bottom, confirming that plasma treatment was performed and adequate adhesive was present around the full tube port.This indicates that the separation of the tubing from the cassette body was due to an adhesive-to-tubing bond failure.A specific cause for the failure could not be conclusively determined.--- the user remains ongoing on their twiist pump.The twiist 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: 50358715
• Report Number: 3016798778-2026-00309
• Device Sequence Number: 10111644
• Product Code: QFG
• UDI-Device Identifier: 00850017421431
• UDI-Public: (01)00850017421431(17)260906
• 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): 08/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/06/2026
• Device Model Number: DKPI-11073-001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/22/2026
• 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: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2025
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 195 LB
• Patient Race: White