MAUDE Adverse Event Report: AMGEN INC. ONPRO KIT; INTRODUCER, SYRINGE NEEDLE

Model Number	9002136
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Neulasta onpro on-body injector flashed a red light instead of a green light after the medication was completely delivered.The red light indicated that a possible error has occurred.

• Brand Name: ONPRO KIT
• Common Device Name: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): AMGEN INC.; 12000 plantside dr.; louisville KY 40299
• MDR Report Key: 11504669
• Report Number: 11504669
• Device Sequence Number: 16879148
• Product Code: KZH
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/11/2021
• Report Date (Section F): 02/11/2021

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: 9002136
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/11/2021