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

Model Number	PT-000409
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The patient's parent reported that the patient attempted to administer meal boluses by entering carbohydrate and blood glucose values into the omnipod app; however, the bolus treatments did not appear in the activity history.The parent stated that insulin did not appear to be delivered, resulting in elevated post-meal blood glucose levels.No error messages were displayed during the reported events.Blood glucose values were not reported.No medical attention was reported.
Additional Manufacturer Narrative
The investigation is currently in progress.A supplementary report will be submitted once the investigation has been completed.We are unable to determine if any product condition could have contributed to the reported event.No lot release records were reviewed, as the product lot number was not provided.Locked down smartphone: phone_control_ios omnipod software app version: 2.2.1 operating system: 26.6 hardware: iphone18.2 cgm sensor type: data not available 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: 50935493
• Report Number: 3014585508-2026-72031
• Device Sequence Number: 15875342
• 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): 09/29/2026

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-000409
• Device Catalogue Number: PDM-H001-G-XX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/29/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown