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	Hypoglycemia (1912)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The physical device was not returned for evaluation.Cloud data from the user for the day of 03feb2026 was downloaded and reviewed.Review of the cloud data confirmed that the reported boluses were delivered at the reported times.The cloud showed that none of the boluses were programmed with a carb or glucose entry and that all were manually adjusted to the total bolus volume.Without application log files, it cannot be determined if the controller was interacted with to program, confirm, and start delivery of these boluses, as the cloud data does not contain records of interactions.The exact cause of the reported uncommanded boluses could not be determined from the available cloud data.Locked down smartphone: phone_control_android omnipod software app version: 3.1.6 operating system: ap3a.240905.015.A2.G991usqsjhzaa hardware: sm-g991u 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
It was reported that the patient noticed several uncommanded boluses after a software update on their android phone.The update was done on (b)(6) 2026 and they experienced uncommanded boluses on (b)(6) 2026, (b)(6) 2026, and (b)(6) 2026.The phone had been located in the backpack of the patient in the school nurse's office and the patient was in physical education class.The unexpected boluses reported that occurred on (b)(6) 2026 were as follows: 09:18 = 5 units; 09:39 = 5 units; 09:54 = 5 units; 10:09 = 2 units; 10:31 = 2 units; 10:38 = 3 units; 13:36 = 1 unit.The patient¿s blood glucose was reported to have been less than 54 mg/dl, but exact results and any treatment provided were not specified.The (b)(6) 2026 event is reported in insulet reference number (b)(4) and the (b)(6) 2026 event is reported in insulet reference number (b)(4).

• 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: derek heyl ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 24570954
• Report Number: 3014585508-2026-13153
• Device Sequence Number: 18234051
• Product Code: QFG
• UDI-Device Identifier: 10385081120302
• UDI-Public: (01)10385081120302
• Combination Product (Y/N): N
• 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): 03/11/2026

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-000559
• Device Catalogue Number: M009-P-AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 03/11/2026
• 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: 9 YR
• Patient Sex: Female