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

Model Number	18900-5A
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Codes	Dehydration (1807); Hyperglycemia (1905); Vomiting (2144); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	01/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient¿s parent reported that the patient was hospitalized on (b)(6) 2026, due to elevated blood glucose (bg) levels displayed as ¿high,¿ indicating levels above 400 mg/dl.No specific bg levels were provided.The patient was diagnosed with diabetic ketoacidosis at the hospital.Reported symptoms included dehydration and vomiting.The parent explained that a pod was not being worn at the time of the medical events because the omnipod controller was not functioning.The parent had contacted product support on january 15 to report that after inserting new batteries, the controller repeatedly powered on and off without displaying an error code or alarm and could not be reset.Due to the nonfunctional controller, the patient was unable to continue omnipod therapy and was reportedly afraid to take manual insulin injections.The patient was treated with intravenous infusions and anti-nausea medication during hospitalization and was discharged on (b)(6) 2026.
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 confirm or determine the root cause of the reported controller failure.Lot release records were reviewed, and the product lot met all acceptance criteria.Specifically, a pod is paired to a pdm and put through simulated use testing including communicating with the pdm, deployment, delivering fluid, occlusion detection, and freedom from hazard alarms.

• 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: 24339702
• Report Number: 3014585508-2026-07656
• Device Sequence Number: 9782176
• Product Code: LZG
• UDI-Device Identifier: 10385081120012
• UDI-Public: (01)10385081120012(11)211025(10)L61366
• 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): 02/13/2026

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: 18900-5A
• Device Catalogue Number: PDM-UST400
• Device Lot Number: L61366
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/13/2026
• Date Device Manufactured: 10/25/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown