MAUDE Adverse Event Report: Insulet Corporation Omnipod Insulin Management System; Pump, Infusion, Insulin

Model Number	19191
Medical Device Problem Codes	Fluid/Blood Leak (1250); Difficult to Insert (1316)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/05/2026
Type of Reportable Event	Malfunction

• Brand Name: Omnipod Insulin Management System
• Common Device Name: Pump, Infusion, Insulin
• 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: 50093841
• Report Number: 3014585508-2026-51542
• Device Sequence Number: 13329881
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033(11)250728(17)270728(10)L72520
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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: 19191
• Device Catalogue Number: ZXP425
• Device Lot Number: L72520
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/10/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/06/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2025
• 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: Male