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 Freezes or Fails to Launch (4031)
Health Effect - Clinical Codes	Dyspnea (1816); Hyperglycemia (1905); Vomiting (2144); Elevated ketones/Diabetic Ketoacidosis (2364); Cognitive Changes (2551)
Date of Event	04/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the complainant the device will not be returned 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, 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: iphone16.2 cgm sensor type: dexcom g6.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 had been hospitalized with diabetic ketoacidosis (dka) on (b)(6) 2026.The patient's blood glucose levels reached greater than 250 mg/dl while wearing the pod.The pod controller generated an "omnipod 5 app error" error message.The patient selected ¿ok¿ to continue; however, the system remained stuck at 8% on the omnipod 5 loading bar after rebooting.They also attempted to restart the app, but it continued to freeze at 8%.Furthermore, they have been unable to administer insulin or control the omnipod since 2:00 pm, subsequently going to the hospital due to feeling unwell.Symptoms reported include vomiting, feeling agitated, difficulty breathing, and experiencing confusion.The patient was treated with zofran for nausea, two unspecified intravenous fluid bags to help stabilize their condition and insulin to help lower their glucose levels.The patient was still admitted at the time of this report.

• 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: 25107755
• Report Number: 3014585508-2026-26247
• Device Sequence Number: 18730640
• 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): 05/06/2026

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?: No
• 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: 04/07/2026
• Initial Report FDA Received Date: 05/06/2026
• 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: 40 YR
• Patient Sex: Unknown