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

Model Number	PT-000409
Medical Device Problem Code	Delayed Program or Algorithm Execution (4034)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when a bolus was commanded on the omnipod dash controller/ personal diabetes manager (pdm) it would not deliver until hours later, resulting in the patient receiving a sudden rush of insulin.The patient¿s blood glucose levels were approximately 20 mmol/l (360 mg/dl) when they administered the bolus.When the bolus didn¿t initially deliver, the patient administered manual injections, but this had caused ¿dangerous lows¿ when the bolus delivered later.No medical assistance was required.
Additional Manufacturer Narrative
The device has not been returned/received to date.If the device is received, a supplemental report will be submitted with the investigation results.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.

• 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: 50946569
• Report Number: 3014585508-2026-72386
• Device Sequence Number: 18749162
• Product Code: QFG
• UDI-Device Identifier: 10385083000022
• UDI-Public: (01)10385083000022(10)L000529
• 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: Foreign,Consumer
• Type of Report: Initial
• 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-000409
• Device Catalogue Number: PDM-H001-G-XX
• Device Lot Number: L000529
• 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: 09/30/2026
• Date Device Manufactured: 02/06/2023
• 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