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

Model Number	18239
Medical Device Problem Code	Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	04/04/2026
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 confirm or determine the root cause of the reported controller malfunction.Lot release records were reviewed, and the product lot met all acceptance criteria.
Event or Problem Description
The patient reported that her glucose levels increased to above 500 mg/dl after the dash controller displayed a boot/recovery mode screen that the patient could not navigate and subsequently turned black.Multiple attempts to reboot the controller were unsuccessful, including battery removal/reinsertion and charging.This resulted in overnight hyperglycemia.The patient reported administering a manual insulin injection, which resulted in severe hypoglycemia, with blood glucose decreasing below 2 mg/dl.She subsequently lost consciousness and was transported by ambulance to the emergency room on (b)(6) 2026, where she remained for approximately seven hours.Reported diagnoses included hypoglycemia, low blood pressure (below 70), atrial fibrillation, and high risk for stroke or heart attack; however, no stroke or heart attack was confirmed.The patient was treated with intravenous glucose and intravenous fluids and returned home the same day.

• 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: 25058378
• Report Number: 3014585508-2026-24944
• Device Sequence Number: 9300560
• Product Code: LZG
• UDI-Device Identifier: 10385082000009
• UDI-Public: (01)10385082000009
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2026

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: 18239
• Device Catalogue Number: USA1-D001-MG-USA1
• Device Lot Number: L000593
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2026
• Initial Report FDA Received Date: 05/01/2026
• Date Device Manufactured: 01/30/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female