MAUDE Adverse Event Report: AMGEN / INSULET CORPORATION NEULASTA ONPRO; INJECTOR, PEN

Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Neulasta device malfunctioned with red light and alarming while patient was leaving the facility.He was able to come back into the center for a second placement without any complication.

• Brand Name: NEULASTA ONPRO
• Common Device Name: INJECTOR, PEN
• Manufacturer (Section D): AMGEN / INSULET CORPORATION
• MDR Report Key: 16700941
• Report Number: MW5116428
• Device Sequence Number: 11960587
• Product Code: NSC
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/03/2023

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: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male