MAUDE Adverse Event Report: Insulet Corporation Omnipod 5 Automated Insulin Delivery System; Alternate Controller Enabled Insulin Infusion Pump

Model Number	PT-000438
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Unintended Movement (3026)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/23/2026
Type of Reportable Event	Malfunction

• Brand Name: Omnipod 5 Automated Insulin Delivery System
• Common Device Name: Alternate Controller Enabled Insulin Infusion Pump
• 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: 50950476
• Report Number: 3014585508-2026-72498
• Device Sequence Number: 10446392
• Product Code: QFG
• UDI-Device Identifier: 10385083000138
• UDI-Public: (01)10385083000138(11)251024(17)271024(10)PH1K10242541
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203768
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: PT-000438
• Device Catalogue Number: POD-BLE-H1-529
• Device Lot Number: PH1K10242541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 10/24/2025
• 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
• Patient Sex: Female