MAUDE Adverse Event Report: MILLYARD ADVANCED MEDICAL PRODUCTS, LLC TWIIST AUTOMATED INSULIN DELIVERY SYSTEM; INFUSION PUMP

Model Number	DKPI-21073-007; DKPI-11073-001
Medical Device Problem Codes	Fluid/Blood Leak (1250); Overheating of Device (1437); Pumping Stopped (1503); Wireless Communication Problem (3283)
Health Effect - Clinical Code	Skin Burning Sensation (4540)
Date of Event	05/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An initial event notification was received by sequel med tech, llc on 18-may-2026 and forwarded to millyard advanced medical products, llc on the same day.The user reported receiving a pump error alarm that they were unable to resolve.The user also reported that when they attempted to disconnect the cassette from the twiist pump, the pump was "so hot it burned" them; however, they denied any injuries due to the heat of the pump.The user further confirmed the presence of moisture inside the pump, and stated that they would revert to multiple daily injections as their backup therapy plan while awaiting a replacement pump.
Additional Manufacturer Narrative
Based on the information available for assessment, a specific cause for the reported event could not be determined.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 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.

• 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: doug shufelt ; 540 n. commercial st.; suite 306; manchester, NH 03101 ; +1(603)206-0591
• MDR Report Key: 25538734
• Report Number: 3016798778-2026-00192
• Device Sequence Number: 21160338
• Product Code: QFG
• UDI-Device Identifier: 00850017421431
• UDI-Public: (01)00850017421431(17)270127
• 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): 10/01/2026

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-21073-007; DKPI-11073-001
• Date Returned to Manufacturer: 05/26/2026
• 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: 05/18/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 06/17/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 24 YR
• Patient Sex: Female
• Patient Weight: 190 LB
• Patient Race: White