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

Model Number	PT-000664
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient received 2 unsolicited boluses from the device.The patient reportedly noticed one of the uncommanded boluses after hearing the pod making a clicking noise.No impact to the patient's blood glucose levels was reported.Medical attention was not required.The patient was requested to upload data logs from the device for investigation.If additional information is received, a supplemental report will be submitted.
Additional Manufacturer Narrative
User-initiated data logs have not been received to date.If user data logs are received, a supplemental report will be submitted with the investigation results.It was reported that the device delivered boluses that were not requested by the patient.We are unable to confirm the reported uncommanded boluses or to determine the root cause.Locked down smartphone: phone_control_ios omnipod software app version: 1.1.6 smartphone operating system: 18.5 smartphone hardware: iphone16.2 cgm sensor type: g6 *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.

• 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: 22241609
• Report Number: 3004464228-2025-26874
• Device Sequence Number: 9098583
• Product Code: QFG
• UDI-Device Identifier: 10385083000336
• UDI-Public: 10385083000336
• 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): 06/17/2025

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-000664
• Device Catalogue Number: M009-S-AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 06/17/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Male