MAUDE Adverse Event Report: Insulet Corporation Omnipod DASH Insulin Management System; Pump, Infusion, Insulin

Model Number	18320
Medical Device Problem Codes	Fluid/Blood Leak (1250); Unintended Movement (3026)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Hyperglycemia (1905)
Date of Event	08/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the legal guardian that the patient's blood glucose level rose to 330 mg/dl while wearing the pod between 5 and 24 hours.When removed from the infusion site (abdomen), the pod's cannula was found to be dislodged and the pod was leaking insulin.The patient also experienced some bleeding.As treatment, a new pod was applied.
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.Lot release records were reviewed, and the product lot met all acceptance criteria.

• 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 ; +1(978)600-7000
• MDR Report Key: 50936672
• Report Number: 3014585508-2026-72075
• Device Sequence Number: 9498896
• Product Code: LZG
• UDI-Device Identifier: 20385082000020
• UDI-Public: (01)20385082000020(11)250528(17)270528(10)PD1K05282521
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 18320
• Device Catalogue Number: BLE-I1-529
• Device Lot Number: PD1K05282521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 05/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male