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

Model Number	14000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/24/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient developed an infection at the pod¿s infusion site (unspecified) while wearing the pod approximately 10 years ago.The patient went to the emergency room and was diagnosed with an unspecified infection.The patient was prescribed unspecified antibiotics.Further details including symptoms, exact date, and specific diagnosis were not available.
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: lockdown omnipod software app version: 4.0.2 operating system: n5004l-am-q-mv01602-06-01.06 hardware: n5004l 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: 50382789
• Report Number: 3014585508-2026-59841
• Device Sequence Number: 9789612
• Product Code: QFG
• UDI-Device Identifier: 20385081120002
• UDI-Public: (01)20385081120002
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 08/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female