MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 ANDROID APP; OMNIPOD 5 APP

Model Number	PT-001788
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cloud data for the period of 11nov2025-13nov2025 was downloaded and reviewed.The cloud data showed two boluses delivered on the date of occurrence (12nov2025), one of 2.75 u and one of 2.3 u.These boluses were delivered approximately 4.5 hours apart and the cloud data showed a completed record for each bolus, indicating that neither bolus was terminated during delivery.Without user-initiated log files, it cannot be determined if other attempts to program and delivery boluses were made on the date of occurrence that did not successfully send or deliver.The exact cause of the reported event could not be determined.Cloud - locked down/smartphone.Phone_control_android.Cloud - omnipod 5 software app version.3.1.1 cloud - operating system bp2a.250605.031.A3.S916usqs6eyj5.Cloud - hardware sm-s916u.Cloud - 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 were administering a bolus using their omnipod 5 application on an iphone, but the application stopped the bolus before completing the entire programmed amount.

• Brand Name: OMNIPOD 5 ANDROID APP
• Common Device Name: OMNIPOD 5 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: 23777988
• Report Number: 3004464228-2025-61698
• Device Sequence Number: 13282834
• Product Code: QFG
• UDI-Device Identifier: 10385083000565
• UDI-Public: (01)10385083000565
• 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): 12/11/2025

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-001788
• Device Catalogue Number: M009-3P-AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 12/11/2025
• 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: 62 YR
• Patient Sex: Female