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

Model Number	18325
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Hyperglycemia (1905); Skin Inflammation/ Irritation (4545)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient's blood glucose level rose to 348 mg/dl while wearing the pod between 4 and 24 hours.The patient reported that the cannula scratched their skin causing bleeding instead of properly seating in the infusion site (arm).As treatment, a new pod was applied.
Additional Manufacturer Narrative
According to our records, the device will not be available for investigation.Therefore, no investigation can be completed and insulet considers this investigation closed.Based on the available information, 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: 50935456
• Report Number: 3014585508-2026-72028
• Device Sequence Number: 9563783
• Product Code: LZG
• UDI-Device Identifier: 20385082000051
• UDI-Public: (01)20385082000051(11)260516(17)280515(10)PD1U05162611
• 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: 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: 18325
• Device Catalogue Number: BLE-P1-525
• Device Lot Number: PD1U05162611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 05/16/2026
• 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: Unknown