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	07/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An initial event notification was received by sequel med tech, llc on 25-jul-2026 and forwarded to millyard advanced medical products, llc on the same day.The user reported that they received pump error alarms from their twiist automated insulin delivery (aid) system.The user's glucose at the time of the alarms was 270 mg/dl.The user gave themselves an injection of lyumjev (insulin lispro) to resolve their glucose and reverted to their backup insulin therapy while awaiting a replacement twiist pump.
Additional Manufacturer Narrative
Investigation into the reported event remains ongoing and a supplemental report will be filed once results are available.Additionally, the user's blood glucose level at the time of the pump error alarm was reported as 270 mg/dl.Based on the information available for assessment, a causal relationship between the device and the reported hyperglycemic event cannot be determined; however, this medical device report conservatively considers the hyperglycemia to be an adverse event.The current version of the twiist automated insulin delivery (aid) 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: doug shufelt ; 540 n. commercial st.; suite 306; manchester, NH 03101 ; +1(603)206-0591
• MDR Report Key: 50417476
• Report Number: 3016798778-2026-00345
• Device Sequence Number: 10659936
• 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: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: 08/03/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2025
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 137 LB
• Patient Race: White