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

Model Number	PT-000559
Medical Device Problem Code	Application Program Problem: Medication Error (3198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physical device was not received for analysis.Cloud data from the user for the period of 08mar2026-10mar2026 was downloaded and reviewed.Review of the bolus records captured in the cloud found no evidence of issues with the bolus records.The cloud data showed that all boluses delivered were correctly calculated based on the glucose and carb inputs, the user's settings, the insulin on board, and the sensor trends at the time of bolus calculation.Without log files, it could not be determined if attempts were made to program boluses that were incorrectly calculated and were not confirmed and started for delivery.The exact cause of the reported incorrect bolus calculations could not be determined from the available cloud data.No lot release records were reviewed, as the product lot number was not provided.Locked down smartphone: phone_control_ios omnipod software app version: 2.1.0 operating system: 18.6 hardware: iphone15.4 cgm sensor type: g6 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 was having issues with the app.The patient could not deactivate the pod or give themself a bolus.When trying to use the bolus calculator, the patient would input values but it was giving them an incorrect amount of units.Impact to patient's blood glucose was not reported.Medical assistance was not required, as a result of this 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: derek heyl ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 24789181
• Report Number: 3014585508-2026-18354
• Device Sequence Number: 9845244
• 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): 04/06/2026

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: 03/10/2026
• Initial Report FDA Received Date: 04/06/2026
• 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 Sex: Unknown