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

Model Number	PT-001827
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The physical device was not returned.Cloud data from the user for the date range of 02august2026-07august2026 was downloaded and reviewed.Review of the patient history buffer (phb) data found that the system was used primarily in automated mode during this period, during which the automated algorithm was able to appropriately adjust the microbolus amounts based on the estimated glucose values and user inputs.The phb data showed that the system was in automated mode on 03august2026 before it was switched to manual mode and back to automated mode again on the same day.The pod began processing invalid estimated glucose values of -2 indicating a link loss state which later transitioned to -5, indicating an unrecoverable sensor error.This error state remained until 13:52 on 06august2026 when the user attempted to pair a new sensor with the pod.As a result of the invalid estimated glucose values, the system was used in automated mode, delivering safe basal, which is the lower of the user's manual basal program and adaptive basal rate, during the time of invalid estimated glucose values.When the system was operating in automated mode, the automated algorithm was able to appropriately adjust based on the estimated glucose values and user inputs.While the system was used in manual mode, the system correctly delivered the user's manual basal program regardless of the estimated glucose values received.The phb data showed that the total pulses delivered count tracked by the pod increased correctly based on the total bolus volume of each bolus after delivery or termination of each bolus, indicating that each bolus was actively delivered by the pod.However, without user-initiated log files, it could not be determined if any issues were present that would prevent the user from initiating a bolus, or if bolus records were correctly displayed on the controller.The cause of the reported event could not be determined.Lot release records were reviewed, and the product lot met all acceptance criteria.Cloud - locked down/smartphone.Lockdown.Cloud - omnipod 5 software app version.4.0.2.Cloud - smartphone operating system.N5004l-am-q-mv01602-06-01.06.Cloud - smartphone hardware.N5004l.Cloud - cgm sensor type.L2+.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: 50569066
• Report Number: 3014585508-2026-63255
• Device Sequence Number: 9927881
• Product Code: QFG
• UDI-Device Identifier: 10385083000022
• UDI-Public: (01)10385083000022(11)250630(10)H000711
• 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,Followup
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: PT-001827
• Device Catalogue Number: PDM-H001-G-XX
• Device Lot Number: H000711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/04/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2025
• 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
• Patient Sex: Female