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

Model Number	PT-000435
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Rash (2033)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the patient that the needle never deployed the cannula into the skin.They also reported that the adhesive caused their skin to break out.The patient was unable to be reached to obtain further information.
Additional Manufacturer Narrative
According to our records, the device will not be available for investigation.Therefore, no investigation can be completed and insulet considers this investigation closed.Based on the available information, 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: data not available omnipod software app version: data not available operating system: data not available hardware: data not available 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 Pod
• 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: 50950420
• Report Number: 3014585508-2026-72488
• Device Sequence Number: 10348445
• Product Code: QFG
• UDI-Device Identifier: 10385083000114
• UDI-Public: (01)10385083000114
• 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-000435
• Device Catalogue Number: POD-BLE-H1-520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/30/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown