MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 POD; ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP

Model Number	PT-000435
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Chest Pain (1776); Discomfort (2330)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Physical device was not received for analysis.Cloud data from the user for the period of (b)(6) 2026-(b)(6) 2026 was downloaded and reviewed.Review of the cloud data confirmed that the last pod used by the user was deactivated at 06:14 on (b)(6) 2026.The patient history buffer (phb) data showed that the user only used the system in manual mode during this period.The phb data showed that the system was correctly delivering the user's manual basal program during this period.The cloud data showed that boluses were being delivered regularly and all notifications, alerts, and reminders were correctly generated as conditions were met.No abnormalities were observed that would contribute to heart palpitations.The exact cause of the reported event could not be determined.No lot release records were reviewed, as the product lot number was not provided.Locked down smartphone: lockdown omnipod software app version: 3.1.6 operating system: n5004l-am-q-mv01602-06-01.06 hardware: n5004l cgm sensor type: unspecified 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.
Event or Problem Description
It was reported that the patient experiences heart palpitations while wearing the pod.Patient visited a cardiologist in 2025; exact date was not provided.Cardiologist prescribed metoprolol, for the heart palpitations.The patient reported later going to endocrinologist, in which they were instructed to go off pod use for a month; but patient reported they plan to go back on in a week and a half.The patient reported that they are sensitive to insulins and frequencies.Customer states they use apidra in the pod.Patient was instructed to speak with healthcare professional about insulin options when they resume pod treatment.No impact to blood glucose levels were reported.

• Brand Name: OMNIPOD 5 POD
• 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 ; 9786007000
• MDR Report Key: 24740894
• Report Number: 3014585508-2026-16916
• Device Sequence Number: 8903842
• Product Code: QFG
• UDI-Device Identifier: 10385083000114
• UDI-Public: (01)10385083000114(17)000101(10)UNAVAILABLE(21)
• Combination Product (Y/N): N
• PMA/510(K) Number: K203768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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-000435
• Device Catalogue Number: POD-BLE-H1-520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female