ARCHITECT CEA

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED POOR REPRODUCIBILITY AND FALSELY DEPRESSED RESULTS WHILE USING ARCHITECT CEA REAGENTS. THE FOLLOWING DATA WAS PROVIDED. PATIENT 1 SID (B)(6) REPEAT USING ANALYZER SN (B)(4) 4.9 IU/ML, INITIAL VALUE WAS HIGHER USING ANOTHER ANALYZER (SN (B)(4)) 937 IU/ML. PATIENT 2 SID (B)(6) REPEAT USING ANALYZER SN (B)(4) 0.5 IU/ML, INITIAL AND REPEAT VALUES WERE HIGHER USING ANOTHER ANALYZER (SN (B)(4)) 5.4, 5.63 IU/ML. PATIENT 3 SID (B)(6) REPEAT USING ANALYZER SN (B)(4) 0.5 IU/ML, INITIAL VALUE WAS HIGHER USING ANOTHER ANALYZER (SN (B)(4)) 4.9 IU/ML. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

EVALUATION OF THE CUSTOMER ISSUE INCLUDED A COMPLAINT TEXT REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, DEVICE HISTORY REVIEW, LABELING REVIEW, ACCURACY TESTING, AND FIELD DATA REVIEW. THE PRODUCT WAS NOT RETURNED. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER ISSUE. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CAUSED THE CUSTOMER ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. AN INTERNAL PANEL WAS TESTED WITH RETAINED KITS OF THE LIKELY CAUSE REAGENT LOT AND ACCURACY TESTING MET ALL SPECIFICATIONS. ABBOTT LINK WORLD WIDE DATA WAS USED TO EVALUATE HISTORICAL PRODUCT FIELD PERFORMANCE. PATIENT DATA WAS ANALYZED THE EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR THE COMPLAINT LOT WAS COMPARABLE TO OTHER LOTS IN THE FIELD BETWEEN JUNE 3, 2018 AND DECEMBER 1, 2018. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS EVALUATION, NO SYSTEMIC ISSUE WAS IDENTIFIED, AND NO PRODUCT DEFICIENCY WAS FOUND.