MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 IOS APP

Model Number	PT-002343
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient history buffer and pod manager history data from the cloud were downloaded for the date of occurrence (b)(6) 2025.User initiated log files were not uploaded to the system.Inspection of the cloud data shows that six different boluses were delivered on the date of occurrence.The boluses were spread out by at least 2 hours each and no instances indicate that 2 boluses were delivered at the same time.Inspection of the patient history buffer indicates the pod delivered the expected amount of pulses for each bolus recorded as well.Although no indication of two boluses being delivered was shown in the cloud data, it could not be conclusively determined whether the omnipod 5 app data was displaying the correct bolus information.The exact cause of the reported event could not be determined.Locked down smartphone: phone_control_ios omnipod software app version: 2.0.4 operating system: 26.0 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.
Event or Problem Description
The patient reported that they experienced an unrequested bolus at the same time as a scheduled bolus from their omnipod 5 application.There was no reported impact on the patient's blood glucose levels.

• 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: 23606816
• Report Number: 3004464228-2025-57724
• Device Sequence Number: 9765529
• Product Code: QFG
• UDI-Device Identifier: 10385083000459
• UDI-Public: (01)10385083000459
• 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): 11/20/2025

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-002343
• Device Catalogue Number: M009-2S-AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Unknown