MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 IOS APP

Model Number	PT-000664
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that that the patient was trying to pause insulin delivery, but the option to pause was missing.The patient was using the system in manual mode.No changes were reported to patient's blood glucose.
Additional Manufacturer Narrative
The physical device was not returned for investigation.Cloud data from the user for the period of (b)(6) 2026-(b)(6) 2026 was downloaded and reviewed.Review of the cloud data found that the system was used partially in manual mode on (b)(6) 2026.No suspension records were seen on this day.The last time that insulin delivery was manually suspended prior to the date of occurrence was on (b)(6) 2026.Without log files, it cannot be determined if the option was available for the user to suspend insulin delivery while in manual mode on (b)(6) 2026 or if attempts were made to suspend insulin delivery while in automated mode on (b)(6) 2026.The exact cause of the reported event could not be determined.According to the complainant the device will not be returned for investigation.Locked down smartphone: phone_control_ios.Omnipod software app version: 2.1.0.Operating system: 26.1.Hardware: iphone17.1.Cgm sensor type: g7.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 IOS APP
• Common Device Name: OMNIPOD 5 IOS APP
• 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: 24809315
• Report Number: 3014585508-2026-18780
• Device Sequence Number: 10678973
• Product Code: QFG
• UDI-Device Identifier: 10385083000336
• UDI-Public: (01)10385083000336
• Combination Product (Y/N): N
• PMA/510(K) Number: K231826
• 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): 04/07/2026

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-000664
• Device Catalogue Number: M009-S-AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Male