MAUDE Adverse Event Report: Insulet Corporation Omnipod Insulin Management System; Pump, Infusion, Insulin

Model Number	19191
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Fatigue (1849); Hyperglycemia (1905); Dizziness (2194); Malaise (2359)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was wearing a pod on the hip/buttocks for between 37 and 48 hours.On (b)(6) 2026, while visiting italy, the patient experienced hyperglycemia with blood glucose reported at 400 mg/dl (22.2 mmol/l) despite multiple correction boluses and minimal food intake.The patient reported increasing ketone levels (approximately 0.4 mmol/l and rising), dizziness, significant weakness, feeling increasingly unwell, and concern that insulin delivery may not have been occurring as expected.The patient reported signs consistent with insulin leakage during wear and reported feeling insulin on the skin.The patient sought medical attention and was treated in the emergency department for approximately 3 hours with intravenous fluids and novorapid insulin.The pod remained in use during medical treatment.After returning to the hotel, the patient removed the pod and applied a new pod filled with novorapid insulin.Blood glucose and ketone levels subsequently improved, and the reported event resolved.
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.

• 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 ; +1(978)600-7000
• MDR Report Key: 50213917
• Report Number: 3014585508-2026-55520
• Device Sequence Number: 17669923
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033(11)250726(17)270726(10)L72519
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: 19191
• Device Catalogue Number: ZXP425
• Device Lot Number: L72519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/11/2026
• Date Device Manufactured: 07/26/2025
• 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: Required Intervention
• Patient Sex: Female