ACCESS® CEA

Additional Manufacturer Narrative

THERE IS NO INDICATION THAT THE ACCESS® CEA DEVICE WAS RETURNED FOR EVALUATION. THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT'S EVENT LOG, TRACE FILES, AND THE ARCHIVE DATA FILE. THERE WAS NO EVIDENCE OF SYSTEM HARDWARE ISSUES. ALL VERIFICATION TESTING PASSED WITHIN PUBLISHED PERFORMANCE SPECIFICATIONS. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, A DEFINITIVE CAUSE OF THE INCIDENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

Description of Event or Problem

THE AFFILIATE STATED THE CUSTOMER REPORTED A FALSELY LOW CARCINOEMBRYONIC ANTIGEN (CEA) RESULT, FOR ONE PATIENT, INVOLVING THE ACCESS® CEA ASSAY USED IN CONJUNCTION WITH THE UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM. AN INITIAL RESULT OF 0.04 NG/ML WAS OBTAINED BUT WAS NOT RELEASED FROM THE LABORATORY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. SUBSEQUENT TESTING OF THE PATIENT'S SAMPLE GENERATED HIGHER RESULTS OF 620.1 NG/ML AND 862.2 NG/ML. THE CUSTOMER NOTED THE FALSELY LOW RESULT WAS GENERATED ON THE LAST REPLICATE OF THE REAGENT PACK. THE CUSTOMER INDICATED QUALITY CONTROL (QC) WAS WITHIN THE ACCEPTABLE RANGE AT THE TIME OF THE EVENT. NO INSTRUMENT ISSUES WERE REPORTED. THE INSTRUMENT WAS IN OPERATION. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.