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

Model Number	PT-000409
Medical Device Problem Codes	Fire (1245); Melted (1385); Overheating of Device (1437); Smoking (1585); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the patient that the omnipod 5 controller/personal diabetes manager (pdm) was charging overnight when they smelled smoke and the pdm "caught on fire," however the patient denied any flames being present.The patient stated that the pdm was smoking, smoldering and the charging port had melted.The controller remained functional until the battery was depleted; however, due to the damaged charging port, it could no longer be recharged.The patient was uncertain whether an insulet-provided charging cable and adapter were being used at the time of the event.The patient stated that the cord they were using was black and there were no prior damages.No harm to the patient was reported and no medical assistance was required.A replacement pdm and charger was issued to the patient.
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 findings.We are unable to confirm or determine the root cause of the reported thermal event.The reported thermal device malfunction is associated with a personal diabetes manager manufactured prior to the correction for action (b)(4) was implemented.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: 50947466
• Report Number: 3014585508-2026-72417
• Device Sequence Number: 9624416
• Product Code: QFG
• UDI-Device Identifier: 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): 09/30/2026

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: H000492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 11/21/2022
• 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