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

Model Number	PT-002516
Medical Device Problem Codes	Fluid/Blood Leak (1250); Difficult to Insert (1316)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient's blood glucose level rose greater than 250 mg/dl while wearing the pod between 24 and 36 hours.The patient reported being unsure if the cannula was properly seated in the infusion site (abdomen) and leaking was observed.
Additional Manufacturer Narrative
The device has not been returned/received to date.If the device is received, a supplemental report will be submitted with the investigation results.We are unable to determine if any product condition could have contributed to the reported event.Lot release records were reviewed and the product lot met all acceptance criteria.Locked down smartphone: lockdown omnipod software app version: 4.0.2 operating system: n5004l-am-q-mv01602-06-01.06 hardware: n5004l cgm sensor type: l2+ please note, the device identifiers are captured as reported by the complainant and may not align with the device configuration reported in this section as this data is pulled from our cloud based on the reported date of event.

• 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: 50950720
• Report Number: 3014585508-2026-72521
• Device Sequence Number: 13369402
• Product Code: QFG
• UDI-Device Identifier: 20385083000425
• UDI-Public: (01)20385083000425(11)260321(17)280321(10)PR1U03212611
• 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: 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-002516
• Device Catalogue Number: POD-OMNI-I1-6220
• Device Lot Number: PR1U03212611
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 03/21/2026
• 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
• Patient Sex: Male