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

Model Number	PT-000559
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Headache (1880); Hyperglycemia (1905)
Date of Event	01/31/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the complainant the device will not be returned for investigation.We are unable to determine if any product condition could have contributed to the reported hyperglycemia.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: iphone14.3.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.
Event or Problem Description
It was reported that the patient sought medical attention on (b)(6) 2026, due to high blood glucose levels and headaches.No specific blood glucose levels were provided.The patient stated she was diagnosed with a hyperglycemic episode and was treated using an insulin sliding scale.She remained in the medical facility for approximately four hours and returned home the same day.Prior to seeking medical attention, the patient reported that she was unable to connect her dexcom g6 continuous glucose monitor transmitter serial number in the omnipod iphone application.No further information was provided despite good-faith efforts to gather additional details.

• 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: 24469239
• Report Number: 3014585508-2026-10643
• Device Sequence Number: 9581244
• 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): 02/27/2026

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-000559
• Device Catalogue Number: M009-P-AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2026
• Initial Report FDA Received Date: 02/27/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male