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

Model Number	PT-000409
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The patient reported that the omnipod 5 touchscreen controller appeared to burn while charging.The patient observed visible burn damage to the charging port, including black residue inside the port, melting on the bottom of the controller, and burning of the serial number label.The patient stated that the controller had been charging for approximately 25 minutes when it became extremely hot and began producing steam/smoke.Following the event, the controller remained partially functional; however, the touchscreen became overly sensitive, and the device would no longer charge properly.The insulet-supplied charging cable was also reported to have sustained damage, with melting observed at the connection point.The damaged charging cable was discarded by the patient.The pod in use on the patient's arm was unaffected by the incident.The patient reported having a backup method of diabetes management available.Blood glucose levels were not reported.Medical attention was not required.The patient will be issued a new device.
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.Locked down smartphone: lockdown.Omnipod software app version: 4.0.2.Operating system: n5004l-am-q-mv01602-06-01.06.Hardware: n5004l.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: 50675562
• Report Number: 3014585508-2026-65128
• Device Sequence Number: 5277712
• Product Code: QFG
• UDI-Device Identifier: 10385083000022
• UDI-Public: (01)10385083000022(11)230518(10)8234
• 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): 09/08/2026

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: 8234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 05/18/2023
• 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: Male