MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 APP; ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP

Model Number	PT-000559
Medical Device Problem Codes	Failure to Deliver (2338); Application Program Problem (2880)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The case description states that the user was unable to bolus due to it being greyed out.The physical controller was not received for investigation.Ios log files from the complaint device were uploaded to the cloud system by the user and downloaded for investigation.Inspection of the ios log files shows that on the date of occurrence, the user was able to successfully navigate to the bolus calculator screen from the home page.Once in the bolus calculator screen, it was observed that the "use sensor" button was not pressed during this time and a bolus was not delivered.However, the user was shown to be able to navigate through the bolus calculator and use the "use sensor" option in order to program and start a bolus on previous days.On the date of occurrence, the user was shown to have valid estimated glucose values (egvs) after entering the bolus calculator.No abnormalities were seen in the log files that would cause the user to be unable to complete bolus programming to deliver a bolus.The exact cause of the reported event could not be determined.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: iphone15.3.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
It was reported that the patient changed the pod and it did not connect with the sensor.Additionally, the smartbolus calculator option was grayed out.Blood glucose levels were reported to be 356 mg/dl.No medical intervention was necessary.

• Brand Name: OMNIPOD 5 APP
• Common Device Name: ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP
• 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: 24829076
• Report Number: 3014585508-2026-19264
• Device Sequence Number: 18753691
• Product Code: QFG
• UDI-Device Identifier: 10385081120302
• UDI-Public: (01)10385081120302
• 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): 04/09/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2026
• Initial Report FDA Received Date: 04/09/2026
• 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 Sex: Unknown