MAUDE Adverse Event Report: AMGEN INC. REPATHA AUTO INJ SURECLICK; INJECTOR PEN

Lot Number	1097865A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Spontaneous inbound call from pt stated that when he went to inject the repatha, the sureclick injector did not release the medication.He tried multiple times and it did not release.Pt stated he then tapped on the pen and it spilled on the table; unable to reach pt, quite possible pt missed one dose and not sure if pt still in possession of defective pen.Reported (b)(6) by pt/caregiver.

• Brand Name: REPATHA AUTO INJ SURECLICK
• Common Device Name: INJECTOR PEN
• Manufacturer (Section D): AMGEN INC.
• MDR Report Key: 8495881
• Report Number: MW5085646
• Device Sequence Number: 19030323
• Product Code: NSC
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2019

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 Expiration Date: 01/31/2021
• Device Lot Number: 1097865A
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR