MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 IOS APP

Model Number	PT-002343
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Unintended System Motion (1430)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cloud data for the period of 27oct2025-29oct2025 was downloaded and reviewed.The cloud data confirmed that a 2.85 u bolus was delivered on the date of occurrence.The cloud data showed that the 2.85 u bolus was based on a sensor entry of 304 mg/dl.This calculation is correct based on the user's correction factor of 55, target blood glucose of 110 mg/dl, insulin on board of 1 u, and the sensor trends at the time the bolus was calculated.Cloud data does not contain logging that shows the interaction with the controller to input values and follow the flow to program, confirm, and deliver the boluses, and so it could not be conclusively determined from the available data if the user interacted with the controller to deliver the 2.85 u bolus.Locked down smartphone: phone_control_ios omnipod software app version: 2.0.4 operating system: 26.0 hardware: iphone16.2 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
The patient reported that they experienced an unrequested bolus of 2.85 units on (b)(6) 2025 during their sleep.Their blood glucose level fell to 30 mg/dl, resulting in a loss of consciousness.Emergency medical services were contacted, and they administered oral glucose along with a sandwich to the patient.Subsequently, the patient was taken to the emergency room where they received additional treatment with oral glucose.

• 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: 23631585
• Report Number: 3004464228-2025-58366
• Device Sequence Number: 10477745
• 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): 11/24/2025

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: 10/30/2025
• Initial Report FDA Received Date: 11/24/2025
• 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: 37 YR
• Patient Sex: Female