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 Code	Lack of Effect (4065)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information available for assessment, a relationship between the twiist automated insulin delivery (aid) system and the reported event cannot be determined.Investigation into the reported event remains ongoing and a supplemental report will be filed once results are available.The user remains ongoing on their twiist pump.The current version of the twiist 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.The cleo 90 infusion set is distributed by millyard advanced medical products, llc, for use with the twiist aid system.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 20-may-2026 and forwarded to millyard advanced medical products, llc on 21-may-2026.The user reported that after performing a cleo 90 infusion site change, on (b)(6) 2026, they delivered a bolus for a salad consumed at lunch, following which, their blood glucose (bg) "skyrocketed".The user delivered an additional bolus via the twiist pump and then changed their infusion site and twiist cassette; however, no change in glucose was observed.The user then administered a manual injection of insulin and their bg began to decline.Later that day, the user's bg elevated between 400-500 mg/dl after consuming only protein at dinner.The user changed the infusion site again and presented to the emergency department (ed).The user remained on the twiist pump during this time and received intravenous fluids, saline, and an exogenous injection.After a few hours, the user's bg began to decline and the user returned home.The user denied damage/issues with the cleo 90 infusion sets, irritation at the infusion sites, issues with the twiist pump, and lifestyle changes, and was advised to contact their health care provider to discuss therapy setting adjustments.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: 25566475
• Report Number: 3016798778-2026-00194
• Device Sequence Number: 15951368
• 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): 06/19/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: DKPI-21073-007; DKPI-11073-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 200 LB
• Patient Race: White