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

Model Number	PT-000559
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the complainant the device will not be returned for investigation.It was reported that the omnipod 5 app had delivered uncommanded boluses.A review of cloud data from the user for the period of 01apr2025 to 06apr2025 found no evidence of the delivery of 16 u then a delivery of 19 u on or around the date of occurrence.No boluses of these amounts were found to be delivered and no sudden large basal/microbolus deliveries were observed.*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.Locked down smartphone: phone_control_ios.Omnipod software app version: 1.1.6.Smartphone operating system: 18.2.Smartphone hardware: iphone17.1.Cgm sensor type: g6.
Event or Problem Description
The patient reported receiving a memory corruption error from his omnipod 5 app that he uses on his ios phone that told him to replace the pod.He uninstalled then reinstalled the omnipod 5 app to clear the alarm and stated without any interaction on his part, when the system started back up, it delivered a total of 19 units of insulin.Patient reported he put the system in activity mode because it was delivering too much insulin.Patient reported consuming 10 glucose packets to keep himself from "crashing".He reported it initially gave 16 units then within 10 minutes it gave another 3 units.No impact to blood glucose levels was provided.The patient did not require medical attention.

• 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: 21943734
• Report Number: 3004464228-2025-19016
• Device Sequence Number: 18343552
• Product Code: QFG
• UDI-Device Identifier: 10385081120302
• UDI-Public: (01)10385081120302
• 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): 05/01/2025

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-000559
• Device Catalogue Number: M009-P-AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2025
• Initial Report FDA Received Date: 05/01/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Male