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

Model Number	PT-000664
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	04/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient experienced hypoglycemia.They stated that the pod delivered a bolus of 2.1 units of insulin automatically without them commanding it to.Their blood glucose decreased to approximately 60 mg/dl, prompting them to contact emergency services (911).Emergency responders advised the customer to remove the pod.The customer reported consuming orange juice afterward, following which their blood glucose levels began to improve.They did not require transport or report any further treatment.
Additional Manufacturer Narrative
The physicial device was not returned for investigation.Cloud data from the user for the day of (b)(6) 2026 was downloaded and reviewed.Review of the cloud data found no boluses delivered of 2.1 u on the date of occurrence.The closest bolus amount found was 2.15 u delivered at 19:42 on (b)(6) 2026.The cloud data showed that this bolus was based on a carb entry of 35 g, which was correctly calculated based on the user's insulin to carb ratio of 1:16.Review of the patient history buffer (phb) data found no abnormally large microboluses recorded.The phb data showed that, while the system was in automated mode, the automated algorithm was able to appropriately adjust the microbolus amounts based on the estimated glucose values and user inputs.Without log files, it could not be determined if the controller was interacted with to program and start the 2.15 u bolus or any of the other boluses recorded in the cloud on this day.The exact cause of the reported uncommanded bolus could not be determined.Cloud - locked down/smartphone phone_control_ios.Cloud - omnipod 5 software app version 2.1.0.Cloud - operating system 26.3.Cloud - hardware iphone17.5.Cloud - 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 CONTROLLER
• 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 ; 9786007000
• MDR Report Key: 25074630
• Report Number: 3014585508-2026-25543
• Device Sequence Number: 10689276
• Product Code: QFG
• UDI-Device Identifier: 10385083000336
• UDI-Public: (01)10385083000336
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 05/04/2026

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-000664
• Device Catalogue Number: M009-S-AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2026
• Initial Report FDA Received Date: 05/04/2026
• 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: 4 YR
• Patient Sex: Male