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	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Dyspnea (1816); Hyperglycemia (1905); Nausea (1970)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 (aid) system user guide provides information about ways to prevent hyperglycemia.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 additional information relevant to the reported event has been made available to millyard advanced medical products, llc, at this time.
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 the same day.The user reported increasing glucose values.Upon inspection, the user noted that the pigtail tubing had detached from the body of the twiist cassette.The user stated the cassette had been placed in her bra and denied any pulling, force, leakage, or alarms associated with the event.Blood glucose increased to 358 mg/dl, confirmed by fingerstick, and subsequently, sensor glucose was >400.The user reported symptoms of nausea and shortness of breath but denied requiring emergency medical services.The user replaced the cassette and infusion set tubing and was able to deliver a bolus via the twiist pump.The user also administered inhaled insulin (afrezza).The user remains ongoing on the 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: courtney mcguirk ; 540 n. commercial st.; suite 306; manchester, NH 03101 ; 6032060591
• MDR Report Key: 25262541
• Report Number: 3016798778-2026-00148
• Device Sequence Number: 10512197
• Product Code: QFG
• UDI-Device Identifier: 00850017421431
• UDI-Public: (01)00850017421431(17)261119
• 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): 05/22/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2025
• 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
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White