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

Model Number	18239
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
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 inability to pause insulin delivery.Lot release records were reviewed and the product lot met all acceptance criteria.
Event or Problem Description
It was reported that on (b)(6) 2026 the patient's blood glucose decreased to 40 mg/dl while wearing the pod between 4 and 24 hours.The patient thought the pod kept delivering insulin even when suspended.When they removed the pod, it still had insulin slowly coming out of the cannula.

• 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: 24629913
• Report Number: 3014585508-2026-14461
• Device Sequence Number: 12936159
• Product Code: LZG
• UDI-Device Identifier: 10385082000009
• UDI-Public: (01)10385082000009(11)230209(10)L000534
• 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): 03/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: L000534
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 03/18/2026
• Date Device Manufactured: 02/09/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Sex: Female