MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD INSULIN MANAGEMENT SYSTEM; PUMP, INFUSION, INSULIN

Model Number	40160
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fatigue (1849); Hyperglycemia (1905); Vomiting (2144); Dizziness (2194)
Date of Event	06/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned/received to date.If the device is received, a supplemental report will be submitted with the investigation results.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.
Event or Problem Description
It was reported by the patient's partner that the patient had been hospitalized with hyperglycemia on (b)(6) 2026.The patient's blood glucose levels reached 53 mmol/l (954 mg/dl) while wearing the pod between 24 and 36 hours on the arm; the patient's usual blood glucose range was reported to be approximately 7 mmol/l (126 mg/dl).The patient had reportedly been feeling unwell throughout the day and experienced vomiting, dizziness, and weakness.The patient's partner reported that the patient was admitted to the intensive care unit (icu) on the evening of (b)(6) 2026.The reported diagnosis was high glucose levels.Treatment reportedly included administration of intravenous fluids and insulin.The patient was still hospitalized at the time of reporting, and therefore a discharge date was not available.Additional information regarding the date of discharge, hospitalization outcome, and any further medical assessment of the relationship between the event and the omnipod system is being requested.The patient continued to wear the pod at the time of the report.

• Brand Name: OMNIPOD INSULIN MANAGEMENT SYSTEM
• Common Device Name: PUMP, INFUSION, INSULIN
• 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: 25762696
• Report Number: 3014585508-2026-44418
• Device Sequence Number: 13236356
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033(11)241204(17)261204(10)L71481
• Combination Product (Y/N): N
• PMA/510(K) Number: K211575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2026

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: 40160
• Device Catalogue Number: POD-ZXR425
• Device Lot Number: L71481
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 07/09/2026
• Date Device Manufactured: 12/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male