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

Model Number	14000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364); Coma (2417); Cognitive Changes (2551)
Date of Event	04/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for investigation.We are unable to determine if any product condition could have contributed to the reported hospitalization and diabetic ketoacidosis.No lot release records were reviewed, as the product lot number was not provided.
Event or Problem Description
A medwatch report was received on 6may2025 that reported the patient developed severe dka (diabetic ketoacidosis) on (b)(6) 2025.The patient is currently intubated and in a coma.The patient also went into cardiac arrest and is reported to have an anoxic brain injury and impending brain herniation.The patient's neuroprognosis was reported to be poor.Additional information was not provided.Due diligence for additional information cannot be completed due to the patient's identification is unknown.

• Brand Name: OMNIPOD INSULIN PUMP
• 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: thom mcnamara ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 22123440
• Report Number: 3004464228-2025-23614
• Device Sequence Number: 7292280
• Product Code: LZG
• UDI-Device Identifier: 20385081120002
• UDI-Public: (01)20385081120002
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K122953
• 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): 06/02/2025

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: 14000
• Device Catalogue Number: ZXP425
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 06/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown