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

Model Number	DKPI-21073-007
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An initial event notification was received by sequel med tech, llc, on 28-mar-2026 and forwarded to millyard advanced medical products, llc, on the same day.The user reported that they received a pump error from their twiist automated insulin delivery (aid) system.The user's glucose at the time of the alarm was 384 mg/dl.The user reverted to a backup insulin therapy while awaiting a replacement twiist pump.
Additional Manufacturer Narrative
Initial event information was received by sequel med tech, llc, on 28-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 non-reportable.Product was later returned to millyard advanced medical products, llc, for investigation on 08-may-2026 and a reportable malfunction was discovered by way of a technical investigation completed on 24-jul-2026.Therefore, for mdr purposes, the date received by the manufacturer (g3) is 24-jul-2026, and the report source (g2) is listed as company representative.Review of the system logs confirmed the reported pump error alarm.Upon disassembly of returned twiist pump, serial number (b)(6), a mechanical malfunction was confirmed, consistent with the reported pump error alarm.A specific cause for the observed malfunction could not be conclusively determined.The contract designer was notified of the investigation findings and will continue to monitor the issue.Additionally, the user's blood glucose level at the time of the pump error alarm was reported as 384 mg/dl.While a causal relationship between the confirmed device malfunction and the reported hyperglycemic event could not be definitively established, this medical device report conservatively considers the hyperglycemia to be an adverse event.----- the twiist automated insulin delivery system user guide provides information regarding system alarms and the recommended actions associated with them, as well as potential causes of hyperglycemia and ways to prevent it.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: courtney mcguirk ; 540 n. commercial st.; suite 306; manchester, NH 03101 ; +1(603)206-0591
• MDR Report Key: 50379330
• Report Number: 3016798778-2026-00331
• Device Sequence Number: 9789445
• Product Code: QFG
• UDI-Device Identifier: 00850017421400
• UDI-Public: (01)00850017421400
• 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): 08/21/2026

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 Model Number: DKPI-21073-007
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/08/2026
• 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: 08/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2025
• 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: 14 YR
• Patient Sex: Male
• Patient Weight: 220 LB
• Patient Race: White