MAUDE Adverse Event Report: AMGEN USA, INC. REPATHA SURECLICK; INJECTOR, PEN

Lot Number	1153233
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient called to report a product issue with her sureclick injector.She stated when the device was filled an air bubble was left on top and she couldn't push the medication through.She stated her neighbor helped her use the shot, but she was very upset that the company was closed for the weekend and there was no support for device issues.Reference report: mw5118153.

• Brand Name: REPATHA SURECLICK
• Common Device Name: INJECTOR, PEN
• Manufacturer (Section D): AMGEN USA, INC.
• MDR Report Key: 17070383
• Report Number: MW5118154
• Device Sequence Number: 12220001
• Product Code: NSC
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 06/05/2023

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
• Device Lot Number: 1153233
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2023
• Patient Sequence Number: 1
• Patient Sex: Female