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

Model Number	18239
Medical Device Problem Codes	No Display/Image (1183); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hyperglycemia (1905); Nausea (1970); Dizziness (2194); Polydipsia (2604)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient went to the emergency room (er) with hyperglycemia.The patient's blood glucose levels exceeded 600 mg/dl due to lack of insulin delivery.The patient reported that the pod controller had a unresponsive, black screen, and was making continuous beeping and vibrating noises.Symptoms reported include thirsty, nausea, and dizziness.The patient was treated with insulin via intravenous (iv) therapy and fluids.The patient was discharged once blood sugar levels decreased on the same day.
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.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: 25480242
• Report Number: 3014585508-2026-34918
• Device Sequence Number: 20271752
• 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): 06/11/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 18239
• Device Catalogue Number: USA1-D001-MG-USA1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/11/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Female