MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 IOS APP

Model Number	PT-002343
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the cloud data showed only one bolus of 0.70 u based on an entry of 35 g of carbs and a 262 mg/dl blood glucose level.This bolus was correctly calculated based on the inputs, user settings, insulin on board, and sensor trend.No boluses of 0.65 u were captured in the cloud; however it was observed that an in-progress record was generated and sent to the cloud where 0.05 u were remaining from the 0.7 u bolus, indicating that 0.65 u had been delivered at the time of the record.It could not be conclusively determined if this in-progress record was being displayed to the user based on the cloud data.The exact cause of the reported event could not be determined.Cloud - locked down/smartphone.Phone_control_ios.Cloud - omnipod 5 software app version.2.0.4.Cloud - operating system.18.7.Cloud - hardware.Iphone14.5.Cloud - cgm sensor type.G7.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.
Event or Problem Description
The patient's parent reported that their omnipod 5 personal diabetes manager administered an unrequested bolus.No additional details were provided.Further information was requested but not obtained.Should any further information be received, a supplementary report will be submitted.

• Brand Name: OMNIPOD 5 IOS APP
• Common Device Name: OMNIPOD 5 IOS APP
• 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 ; 9786007000
• MDR Report Key: 23575397
• Report Number: 3004464228-2025-56802
• Device Sequence Number: 15835929
• Product Code: QFG
• UDI-Device Identifier: 10385083000459
• UDI-Public: (01)10385083000459
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2025

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-002343
• Device Catalogue Number: M009-2S-AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/17/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Sex: Female