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	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient's blood glucose level rose to over 400 mg/dl while wearing the pod between 4 and 24 hours.The patient reported the pod was leaking and being unsure if the cannula was properly seated in the infusion site (arm).As treatment, a new pod was applied and a bolus was administered.
Additional Manufacturer Narrative
The device has been returned; however, the investigation is not yet complete.When the investigation is complete, a supplemental report will be submitted with the investigation results.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: abbott freestyle libre 2 plus.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: 50932564
• Report Number: 3014585508-2026-71951
• Device Sequence Number: 21231947
• Product Code: QFG
• UDI-Device Identifier: 20385083000425
• UDI-Public: (01)20385083000425(11)260319(17)280319(10)PR1U03192611
• 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): 09/29/2026

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: PR1U03192611
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2026
• 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