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

Model Number	19191
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Stroke/CVA (1770); Cognitive Changes (2551)
Date of Event	12/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the complainant the device will not be returned for investigation.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.
Event or Problem Description
It was reported that, on (b)(6) 2024, the patient was hospitalised at (b)(6), including admission to the intensive care unit, with a diagnosis of a basal ganglia haemorrhage.The patient was using omnipod eros system at the time of the event but it was immediately disposed of on admission.The name of the healthcare professional who treated the patient was not recalled by the complainant.Treatment the patient received included thrombo ass, cerebokan and pronerv.The patient's wife stated the event was not linked to a device failure but likely a complication from a longstanding diagnosis of diabetes.The patient resumed omnipod system use in (b)(6) 2025.As a result of the haemorrhage, the patient has ongoing cognitive impairment and impaired motor function.The patient was hospitalised for a total of 37 days ((b)(6) 2025).

• Brand Name: OMNIPOD INSULIN MANAGEMENT SYSTEM
• Common Device Name: 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: 25124631
• Report Number: 3014585508-2026-26812
• Device Sequence Number: 8634582
• Product Code: QFG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033
• 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: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 19191
• Device Catalogue Number: ZXP425
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/08/2026
• 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
• Outcome Attributed to Adverse Event: Disability; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male