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

Model Number	PT-000559
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient¿s father reported that medical attention was sought on (b)(6) 2026, due to concerns related to elevated blood glucose (bg) levels and ketones.No specific bg levels were reported.The father stated that while the patient attempted to change the pod, an application error occurred.Due to the application error, the patient was unable to navigate within the app and was unable to successfully replace the pod.The father reported that the patient¿s ketone level was 2.8, and blood glucose levels were elevated.No additional symptoms were reported.Troubleshooting was performed with insulet product support; however, the error did not clear.Due to the lack of a backup insulin delivery method and the unresolved application error, the patient presented to the hospital for evaluation and treatment.The patient was treated with intravenous fluids and insulin and was discharged the same day after a few hours.
Additional Manufacturer Narrative
According to the complainant the device will not be returned for investigation, and application log files are currently unavailable.We are unable to confirm or determine the root cause of the reported omnipod application error.Lot release records were reviewed, and the product lot met all acceptance criteria.Specifically, a pod is paired to a pdm and put through simulated use testing including communicating with the pdm, deployment, delivering fluid, occlusion detection, and freedom from hazard alarms.Locked down smartphone: phone_control_ios.Omnipod software app version: 2.1.0.Operating system: 26.2.Hardware: iphone14.7.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.

• 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: 24316946
• Report Number: 3014585508-2026-06965
• Device Sequence Number: 12181717
• Product Code: QFG
• UDI-Device Identifier: 10385081120302
• UDI-Public: (01)10385081120302(11)250828(17)270828(10)PH1U08282522
• 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): 02/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: PT-000559
• Device Catalogue Number: M009-P-AP
• Device Lot Number: PH1U08282522
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/11/2026
• Date Device Manufactured: 08/28/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR
• Patient Sex: Female