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	Material Separation (1562)
Health Effect - Clinical Codes	Hyperglycemia (1905); Nausea (1970)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The current version of the twiist automated insulin delivery system user guide provides information about the potential causes of hyperglycemia and how to prevent it.Users are also instructed to have a backup insulin therapy available at all times.The user remains ongoing on their twiist pump.No components or additional information relevant to the reported event have been made available to millyard advanced medical products, llc, for further investigation.
Event or Problem Description
An initial event notification was received by sequel med tech, llc, on (b)(6) 2026 and forwarded to millyard advanced medical products, llc on 08-may-2026.The user reported a hyperglycemic event with a glucose value of 401mg/dl on (b)(6) 2026.The user reported that the twiist cassette tubing appeared to have broken off near the leur lock connector while they were at work and they had not noticed that insulin was not being delivered.The user changed out the twiist cassette and infusion set tubing.The user further started that they would turn loop off, administer a manual insulin bolus of 8 units, and continue to monitor their glucose values.The user experienced nausea but confirmed they did not require emergency medical services.The user remains ongoing on their twiist pump.

• 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: meagan armstrong ; 540 n. commercial st.; suite 306; manchester, NH 03101 ; 6032060591
• MDR Report Key: 25416711
• Report Number: 3016798778-2026-00175
• Device Sequence Number: 9613776
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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-11073-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White