ARCHITECT CEA REAGENT KIT

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, DEVICE HISTORY RECORDS, AND CUSTOMER FIELD DATA. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW ON LOT 12001FN01 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. PER PRODUCT LABELLING, A SERUM OR PLASMA CEA LEVEL, REGARDLESS OF VALUE, SHOULD NOT BE INTERPRETED AS ABSOLUTE EVIDENCE FOR THE PRESENCE OR ABSENCE OF MALIGNANT DISEASE. THE CEA LEVEL SHOULD BE USED IN CONJUNCTION WITH INFORMATION AVAILABLE FROM CLINICAL EVALUATION AND OTHER DIAGNOSTIC PROCEDURES. THE HISTORICAL PERFORMANCE OF REAGENT LOT 12001FN01 WAS EVALUATED USING WORLDWIDE DATA. THE PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR LOT 12001FN01 IS WITHIN THE ESTABLISHED CONTROL LIMITS, THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CEA ASSAY FOR LOT NUMBER 12001FN01 WAS IDENTIFIED.

Additional Manufacturer Narrative

NO FURTHER PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. 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 A FALSELY ELEVATED ARCHITECT CEA (CARCINOEMBRYONIC ANTIGEN) RESULT FOR A (B)(6) YEAR OLD MALE PATIENT DIAGNOSED WITH RECTAL MT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE FOR ARCHITECT AND BECKMAN: 0 TO 5 NG/ML): ON (B)(6) 2020 INITIAL RESULT WITH ARCHITECT = 97.22 NG/ML, THIS SAMPLE WAS DISCARDED AND COULDN¿T BE RETESTED. ON (B)(6) 2020 INITIAL RESULT WITH BECKMAN = 4.63 NG/ML, SAMPLE WAS REPEATED ON THE ARCHITECT AND GENERATED RESULTS WITHIN THE REFERENCE RANGE. THE PATIENT HAD A PET/CT SCAN PERFORMED ON (B)(6) 2020 WITH IV CONTRAST DUE TO HIS DIAGNOSIS AND THE FALSELY ELEVATED ARCHITECT CEA RESULTS. THE PATIENT HAS NOT BEEN BACK FOR A FOLLOW-UP SO THERE IS NO INFORMATION AS TO IMPACT ON PATIENT HEALTH DUE TO THE IV CONTRAST. NO ADDITIONAL IMPACT TO THE PATIENT WAS REPORTED.