MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 IOS APP

Model Number	PT-000664
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Application Program Problem: Medication Error (3198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient experienced two instances where they went to bolus and input 10 g of carbs, but the system changed what should be delivered for the bolus up to 10 units of insulin.Additionally, they paused insulin delivery, but they thought it kept delivering.The patient removed the pod.The patient did not require medical intervention or treatment.The first instance of the same thing is reported in insulet case reference # (b)(4).
Additional Manufacturer Narrative
The physical device was not returned for investigation.Cloud data from the user for the period of 20mar2026-24mar2026 was downloaded and reviewed.Review of the cloud data found that a 10 u bolus was started at 14:58 on 24mar2026.This bolus was based on a carb entry of 22 g.The cloud data shows that the bolus calculator correctly calculated a bolus of 2.4 u based on the 22 g of carbs and an insulin to carb ratio of 9, however this bolus was then manually adjusted from 2.4 u to 10 u.It could not be conclusively determined if this was the only attempt to program a bolus that resulted in a total bolus volume of 10 u from the available cloud data.Review of the patient history buffer (phb) data found that the user was able to suspend insulin delivery at 15:42 on 24mar2026, with insulin delivery remaining suspended until a pod deactivation at 16:35 on 24mar2026.The phb data confirmed that no insulin was being actively delivered during this period, as the total pulses delivered count tracked by the pod did not increase during this suspension period.It could not be determined if errors occurred prior to this that prevented the user from pausing insulin delivery from the available cloud data.The exact cause of the reported incorrect bolus calculation and inability to pause insulin delivery could not be determined from the available cloud data.Locked down smartphone: phone_control_ios omnipod software app version: 2.1.0 operating system: 18.7 hardware: iphone16.1 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 IOS APP
• Common Device Name: OMNIPOD 5 IOS APP
• 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: 24965745
• Report Number: 3014585508-2026-22451
• Device Sequence Number: 20078396
• Product Code: QFG
• UDI-Device Identifier: 10385083000336
• UDI-Public: (01)10385083000336
• Combination Product (Y/N): N
• 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): 04/23/2026

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: 03/24/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female