MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 IOS APP

Model Number	PT-000664
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The physical device was not returned for investigation.Cloud data from the day of (b)(6) 2026 was downloaded and reviewed.Review of the data found that a single bolus of 2.15 u was programmed and delivered on this day.The data showed that this 2.15 u bolus was based on a manual blood glucose entry of 257 mg/dl and an insulin on board of 0 u at the time of the calculation.No carbs were entered and no manual adjustments were made to the total volume.The 2.15 u bolus was correctly calculated based on the user's target of 110 mg/dl and correction factor of 68.Without log files, it cannot be determined if the controller was interacted with the program and start the 2.15 u bolus.The exact cause of the reported uncommanded bolus was observed in the available cloud data.No lot review was completed because the suspect product is the iphone application.Locked down smartphone: phone_control_ios.Omnipod software app version: 2.1.0.Operating system: 18.7.Hardware: iphone15.5.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 an uncommanded bolus was delivered on (b)(6) 2026.The patient stated that they never administered a bolus, however, her application was showing bolus readings recorded for that day.No further information was reported.Multiple attempts were made to reach the reporter for further information, however, were unsuccessful.

• 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: 25249886
• Report Number: 3014585508-2026-29823
• Device Sequence Number: 18767015
• Product Code: QFG
• UDI-Device Identifier: 10385083000336
• UDI-Public: (01)10385083000336
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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): 05/21/2026

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: 04/24/2026
• Initial Report FDA Received Date: 05/21/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female