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

Model Number	PT-000559
Medical Device Problem Code	Program or Algorithm Execution Failure (4036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
They physical device was not returned for investigation.Cloud data from the user for the period of 01feb2026-16feb2026 was downloaded for review.Review of the cloud data found no instances of temp basal being activated during this period.It was noted in the patient history buffer data that the system was primarily used in automated mode, with the only transitions to manual mode occurring to change pods.System mode switch to manual mode is required to enable temp basals.Without log files, it cannot be determined if attempts were made to navigate to the temp basal menu and activate temp basals that were unsuccessful.The exact cause of the reported event could not be determined.Locked down smartphone: phone_control_android.Omnipod software app version: 3.1.6.Operating system: bp2a.250605.031.A3.S936usqs7bylr.Hardware: sm-s936u.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
It was reported that the patient was not able to use a temporary basal rate on the android omnipod application.No further information was provided.

• 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: 24626748
• Report Number: 3014585508-2026-14433
• Device Sequence Number: 8689211
• Product Code: QFG
• UDI-Device Identifier: 10385083000565
• UDI-Public: (01)10385083000565
• 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): 03/18/2026

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-000559
• Device Catalogue Number: M009-P-AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 03/18/2026
• 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: 57 YR
• Patient Sex: Male