ARCHITECT CEA

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR THE OBSERVED POTENTIAL FALSE DEPRESSED CEA RESULT INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELLING, AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. PERFORMANCE OF REAGENT LOT 09006FN00 WAS EVALUATED USING WORLD WIDE DATA FROM ABBOTTLINK. THE PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR LOT 09006FN00 IS WITHIN THE ESTABLISHED CONTROL LIMITS, THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED. TRENDING REVIEW DETERMINED NO ADVERSE TREND FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW ON LOT 09006FN00 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CEA ASSAY, LOT NUMBER 09006FN00 WAS IDENTIFIED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

Description of Event or Problem

THE CUSTOMER STATED THAT A FALSELY DECREASED ARCHITECT CEA RESULT OF 0.9 NG/ML WAS GENERATED ON (B)(6) 2020, AND DID NOT MATCH THE PATIENT'S HISTORICAL OR SUBSEQUENT TESTING. THE SAMPLE WAS NOT AVAILABLE FOR REPEAT TESTING. SID: (B)(6): 0.9 NG/ML; (B)(6) 2020. SID: (B)(6): 3329.7 NG/ML; (B)(6) 2020. (AGREES WITH PREVIOUS TESTS AND PATIENT HISTORY). NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.