MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 IOS APP

Model Number	PT-002343
Medical Device Problem Codes	Communication or Transmission Problem (2896); Reset Problem (3019)
Health Effect - Clinical Codes	Dyspnea (1816); Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Burning Sensation (2146); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient removed a pod and reinstalled the omnipod 5 application following a "pod is no longer connected to app, remove app and reinstall" alert on the app.Around the same time, the patient received a maximum storage alert on his iphone.Following the app reinstallation, the patient's setting on the app was erased and the patient was unable to resume treatment.The patient had no backup insulin available at that time.Consequently, the patient experienced hyperglycemia and was hospitalized with diabetic ketoacidosis on (b)(6) 2025.Symptoms reported include hyperglycemia, burning sensation, chemical taste in the mouth, nausea, vomiting, dyspnea, and sweating.The patient was treated with intravenous insulin and fluids.The patient was released the following day (b)(6) 2025f.
Additional Manufacturer Narrative
The device will not be available for investigation.We are unable to determine if any product condition could have contributed to the reported hospitalization and diabetic ketoacidosis.No lot release records were reviewed.Locked down smartphone: not available.Omnipod software app version: not available.Operating system: not available.Hardware: not available.Cgm sensor type: 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.

• 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: 23787407
• Report Number: 3004464228-2025-61926
• Device Sequence Number: 5546330
• 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): 12/12/2025

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-002343
• Device Catalogue Number: M009-2S-AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 12/12/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 43 YR
• Patient Sex: Male