MAUDE Adverse Event Report: Insulet Corporation Omnipod 5 iOS App

Model Number	PT-000664
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Codes	Hypoglycemia (1912); Malaise (2359); Syncope/Fainting (4411)
Date of Event	07/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient visited the emergency room with hypoglycemia on (b)(6) 2026.The patient's blood glucose levels declined to 50 mg/dl while wearing the pod(leg).The patient stated that they had transferred omnipod 5 therapy settings to a new phone application and may have entered settings incorrectly during the phone change, which resulted in receiving more insulin than expected.Symptoms reported include malaise and fainting.The patient was treated with intravenous (iv) fluids and was released the same day.The pod was discarded.
Additional Manufacturer Narrative
According to the complainant the device will not be available for investigation because it was discarded.We are unable to determine if any product condition could have contributed to the reported event.Lot release records were reviewed, and the product lot met all acceptance criteria.Locked down smartphone: phone_control_ios.Omnipod software app version: 3.1.6.Operating system: n5004l-am-q-mv01602-06-01.06.Hardware: n5004l.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.

• 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 ; +1(978)600-7000
• MDR Report Key: 50135553
• Report Number: 3014585508-2026-52948
• Device Sequence Number: 17539028
• Product Code: QFG
• UDI-Device Identifier: 10385083000336
• UDI-Public: (01)10385083000336(11)260215(17)280215(10)PR1K02152621
• Combination Product (Y/N): N
• 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
• Type of Report: Initial
• Report Date (Section B): 08/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: PT-000664
• Device Catalogue Number: M009-S-AP
• Device Lot Number: PR1K02152621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 08/04/2026
• Date Device Manufactured: 02/15/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female