MAUDE Adverse Event Report: Insulet Corporation Omnipod 5 iOS App

Model Number	PT-001662
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hyperglycemia (1905); Cognitive Changes (2551)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient went to the emergency room (er) with hyperglycemia on (b)(6)2026.The patient's blood glucose levels reached over 500 mg/dl while wearing the pod between 4 and 24 hours.The pod was worn on the arm.The patient reported having lost the phone where the omnipod 5 application was manged, which contributed to the elevated blood glucose.Symptoms reported include confusion.The patient was treated with insulin.The patient was discharged the same day.The pod was removed at the hospital so that the patient could get a magnetic resonance imaging (mri).
Additional Manufacturer Narrative
According to our records, the device will not be available for investigation.Therefore, no investigation can be completed and insulet considers this investigation closed.Based on the available information, we are unable to determine if any product condition could have contributed to the reported event.Lot release records were reviewed, and the product lot met all acceptance criteria.Locked down smartphone: phone_control_ios omnipod software app version: 2.2.1 operating system: 26.5 hardware: iphone17.3 cgm sensor type: dexcom 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 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 ; +1(978)600-7000
• MDR Report Key: 50178156
• Report Number: 3014585508-2026-54242
• Device Sequence Number: 18203539
• Product Code: QFG
• UDI-Device Identifier: 10385083000336
• UDI-Public: (01)10385083000336(11)260305(17)280305(10)PR1M03052641
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K231826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

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-001662
• Device Catalogue Number: POD-OMNI-I1-6720
• Device Lot Number: PR1M03052641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/09/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 08/31/2026
• Date Device Manufactured: 03/05/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male