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	03/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the complainant the device will not be returned for investigation.We are unable to confirm the reported application software failure or determine its root cause.No lot release records were reviewed, as the product lot number was not provided.Locked down smartphone: phone_control_ios.Omnipod software app version: 2.1.0.Operating system: 26.2.Hardware: iphone16.1.Cgm sensor type: data not available.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
The patient reported the inability to pause insulin delivery through the omnipod app.The patient replaced the pod due to decreasing blood glucose levels.No specific blood glucose levels were reported.There was no medical intervention reported in relation to this event.
Additional Manufacturer Narrative
The physical device was not returned for investigation.Cloud data tied to the user for the day of (b)(6) 2026 was downloaded for investigation.Review of the cloud data found several instances of insulin delivery being paused on (b)(6) 2026.The user was notified each time the suspension period was met, and the system continued to suspend insulin delivery until basal insulin delivery was resumed.The patient history buffer data confirmed that during each period of insulin suspension, the number of pulses delivered by the pod did not increase.No issues were observed in the available cloud data with the system's ability to pause insulin as expected; however, without application logs, it could not be determined if an issue occurred that prevented the user from pausing insulin delivery at some point on the date of occurrence.The cause of the reported event could not be determined.

• 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: 24758106
• Report Number: 3014585508-2026-17439
• Device Sequence Number: 15661931
• 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,Followup
• Report Date (Section B): 04/03/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/03/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Female