ARCHITECT CEA

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4). AN EVALUATION IS IN PROCESS.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY DEPRESSED AND ERRATIC CEA RESULTS FOR ONE PATIENT ON THE ARCHITECT I1000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL > 1500, AUTODILUTION 674.18, REPEATED NEAT > 1500, AUTODILUTION 710.52 NG/ML. PER MANUAL DILUTION THE CUSTOMER OBTAINED THE FOLLOWING RESULTS: 272, 344.47, 336.14 AND 741.02 NG/ML. ADDITIONAL REPEATS OF 846.25, 966, 475 NG/ML. THE PATIENT HAS NO PREVIOUS CEA RESULTS, BUT HAS BEEN DIAGNOSED WITH BREAST CANCER WITH LIVER METASTIZED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING, AND TESTING (SENSITIVITY AND ACCURACY). NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE CUSTOMER OBSERVATION WAS REPEATED UPON SUBSEQUENT TESTING IN-HOUSE OF THE RETURNED PATIENT SPECIMEN (ORIGINAL SAMPLE AND REDRAW). ACCURACY AND SENSITIVITY TESTING MET ALL SPECIFICATIONS. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, THE ASSAY PERFORMED AS INTENDED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED.