MAUDE Adverse Event Report: Insulet Corporation Omnipod 5 Controller; Alternate Controller Enabled Insulin Infusion Pump

Model Number	PT-001827
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Codes	Hypoglycemia (1912); Cognitive Changes (2551)
Date of Event	08/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the omni pod 5 controller/ personal diabetes manager (pdm) delivered two uncommand boluses.The first was 10 units delivered on (b)(6) 2026 (insulet reference number (b)(4) did not require medical assistance) and the second was 15 units on (b)(6)2026 (insulet reference number (b)(4).The second uncommanded bolus resulted in the patient experiencing hypoglycemia and requiring ems to administer intravenous dextrose.The patient blood glucose level had declined to 21 mg/dl.It was reported that the pdm was next to the patient at the time of the event, on the arm of their chair.
Additional Manufacturer Narrative
The physical device was not returned for investigation.The case description states two uncommand boluses of 10 u and 15 u resulted in hypoglycemia.The physical controller was not received for investigation.Ios log files from the complaint device were uploaded to the cloud system by the user and downloaded for investigation.Investigation of the ios log files confirmed the 10 u bolus was delivered on (b)(6) 2026 and 15 u bolus was delivered on (b)(6) 2026.The log files showed each bolus amount was typed in one digit at a time and confirm and start boluses were tapped.Each bolus had records of controller interactions in the log files.No evidence of an uncommand bolus was observed.Locked down smartphone: phone_control_ios, omni pod software app version: 2.2.1, operating system: 26.5, 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 Controller
• 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 ; +1(978)600-7000
• MDR Report Key: 50911707
• Report Number: 3014585508-2026-71521
• Device Sequence Number: 5776865
• Product Code: QFG
• UDI-Device Identifier: 10385083000022
• UDI-Public: (01)10385083000022
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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-001827
• Device Catalogue Number: PDM-H001-G-XX
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/01/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female