MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 APP; ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP

Model Number	PT-001788
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The physical device was not returned for investigation.Cloud data for the period of 01jun2025-06jun2025 was reviewed.Review found that the system was not delivering insulin while insulin delivery was paused.The patient history buffer data showed no increase in the total pulse count recorded by the pods while insulin delivery was suspended, confirming that the pods were not actively delivering insulin and were not commanded to deliver insulin during these pause periods.No evidence of issues were observed with the system in the available cloud data.Locked down smartphone: phone_control_android omnipod software app version: 3.1.1 smartphone operating system: ap3a.240905.015.A2.S926usqs4bye4 smartphone hardware: sm-s926u cgm sensor type: g7.*please note, that section d is capturing the device identifiers as reported by the complainant.This may not align to the device configuration reported in h11, as this data is pulled from our cloud based on the reported date of event.
Event or Problem Description
The patient reported the omnipod system continued to deliver insulin after insulin delivery was paused.No impact to the patient's blood glucose levels was reported.No medical attention was required.If additional information is received, a supplemental report will be submitted.

• Brand Name: OMNIPOD 5 APP
• 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: thom mcnamara ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 22375586
• Report Number: 3004464228-2025-29274
• Device Sequence Number: 4644482
• Product Code: QFG
• UDI-Device Identifier: 10385083000565
• UDI-Public: 10385083000565
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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-001788
• Device Catalogue Number: M009-3P-AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Male