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

Model Number	PT-002516
Medical Device Problem Codes	Fluid/Blood Leak (1250); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the patient the cannula retracted, indicating a needle mechanism failure.No impact to the patient's blood glucose level was reported.The pod was worn for less than one hour.When the pod was removed from the infusion site, it was observed there was leaking.There was no report of medical intervention.
Additional Manufacturer Narrative
The pod was received with the needle mechanism assembly deployed.The pod data showed no alarms, timeouts, or drive stalls.The pod deactivated after running 55 pulses, deactivating at the end of second prime.The pod data showed no issues in the first or second prime sequences when the needle would deploy.Inspection of the needle mechanism assembly, hard cannula, environmental seal, and bottom housing found no damages or deficiencies that would contribute to a cannula retraction.Though no issues were observed, it could not be determined when the needle mechanism deployed.Therefore, the cause of the reported needle mechanism failure event could not be determined.Fluid had no issues traveling the complete fluid path and no leaks were found.No problem was found regarding the reported leaking during wear event.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 Automated Insulin Delivery System
• 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: 50931737
• Report Number: 3014585508-2026-71934
• Device Sequence Number: 16142207
• Product Code: QFG
• UDI-Device Identifier: 20385083000425
• UDI-Public: (01)20385083000425(11)260617(17)280617(10)PR1U06172621
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K231826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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-002516
• Device Catalogue Number: POD-OMNI-I1-6220
• Device Lot Number: PR1U06172621
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2026
• 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: Male