MAUDE Adverse Event Report: Insulet Corporation Omnipod 5 Controller; Alternate Controller Enabled Insulin Infusion Pump

Model Number	PT-001827
Medical Device Problem Code	Problem with Software Installation (3013)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was hospitalized with high blood glucose (bg) in (b)(6) 2026.The patient's blood glucose levels reached 1130 mg/dl.The patient stated that she wasn't able to get into her account in the omnipod 5 controller because she had to hard reset it because the device had an issue where it was stuck on app initialization " loading screen" at step 19 /29 and then started again while trying to turn it on but was able to get in the log in screen after a hard reset.She said as a result, she was not receiving the insulin she needed since the omnipod 5 controller wasn't working.The patient diagnosis was that she had high blood glucose levels because she was unable to receive her insulin at the time.The patient was treated with 15 units of insulin.The patient was discharged after a half a day on (b)(6) 2026. .
Additional Manufacturer Narrative
According to our records, the device will not be available for investigation.Therefore, no investigation can be completed and insulet considers this investigation closed.Based on the available information, 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: lockdown.Omnipod software app version: 3.1.6.Operating system: n5004l-am-q-mv01602-06-01.06.Hardware: n5004l.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 Controller
• 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 ; +1(978)600-7000
• MDR Report Key: 50419267
• Report Number: 3014585508-2026-60319
• Device Sequence Number: 16117195
• Product Code: QFG
• UDI-Device Identifier: 10385083000022
• UDI-Public: (01)10385083000022(11)250109(10)H000653
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: PT-001827
• Device Catalogue Number: PDM-H001-G-XX
• Device Lot Number: H000653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Date Device Manufactured: 01/09/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female