MAUDE Adverse Event Report: AMGEN REPATHA AUTO-INJ SURECLICK

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Arrest (1762)

Event Type  Injury  

Event Description

Patient stated that his heart stopped and he was in the hospital.He is now released.Prescriber aware.Patient will continue on medication.Reported to (b)(6) by: patient/caregiver.Dose or amount: 140 mg; frequency: once every two weeks; route: subcutaneously.Dates of use: from (b)(6) 2016 to current.Diagnosis or reason for use: hyperlipidemia.

• Brand Name: REPATHA AUTO-INJ SURECLICK
• Type of Device: REPATHA AUTO-INJ SURECLICK
• Manufacturer (Section D): AMGEN
• MDR Report Key: 8253836
• MDR Text Key: 133688202
• Report Number: MW5083180
• Device Sequence Number: 1
• Product Code: NSC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization