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

Model Number	18320
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hyperglycemia (1905); Vomiting (2144); Malaise (2359); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	06/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was transported to the emergency room by ambulance and subsequently admitted to southampton general hospital with diabetic ketoacidosis (dka) on (b)(6) 2025.While wearing the pod between 37 and 48 hours, the patient¿s blood glucose levels reportedly rose to the high 20 mmol/l range (around 360 mg/dl).The patient attempted multiple correction boluses with no effect on glucose levels.The patient initially believed the symptoms were related to food poisoning, but as the condition worsened¿marked by hyperglycemia, vomiting, and lethargy¿medical services were contacted.The patient was treated with intravenous fluids and an insulin drip.The pod was removed and discarded at the hospital.The patient was discharged the following day, (b)(6) 2025, after approximately 16 hours of hospitalization.
Additional Manufacturer Narrative
According to the complainant the device will not be available for investigation because it was discarded.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.

• Brand Name: OMNIPOD DASH 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: 24738514
• Report Number: 3014585508-2026-16893
• Device Sequence Number: 8843390
• Product Code: LZG
• UDI-Device Identifier: 20385082000020
• UDI-Public: (01)20385082000020
• 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): 03/30/2026

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: 18320
• Device Catalogue Number: BLE-I1-529
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/31/2026
• 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 Age: 39 YR
• Patient Sex: Female