MAUDE Adverse Event Report: Insulet Corporation Omnipod 5 Automated Insulin Delivery System

Model Number	PT-001446
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Urinary Frequency / Polyuria (2275); Elevated ketones/Diabetic Ketoacidosis (2364); Polydipsia (2604)
Date of Event	09/21/2026
Type of Reportable Event	Serious Injury

• Brand Name: Omnipod 5 Automated Insulin Delivery System
• Common Device Name: Automated Insulin Delivery System
• Manufacturer (Section D): Insulet Corporation; 100 nagog park; acton MA 01720
• Manufacturer (Section G): Insulet Corporation; 100 nagog park; acton MA 01720
• Manufacturer Contact: derek heyl ; 100 nagog park; acton, MA 01720 ; +1(978)600-7000
• MDR Report Key: 50955137
• Report Number: 3014585508-2026-72643
• Device Sequence Number: 21444126
• Product Code: QFG
• UDI-Device Identifier: 20385083000548
• UDI-Public: (01)20385083000548(11)260216(17)280216(10)PH1K02162651
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K231826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: PT-001446
• Device Catalogue Number: POD-OMNI-I1-6720
• Device Lot Number: PH1K02162651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 02/16/2026
• 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: Hospitalization
• Patient Sex: Female