ARCHITECT CEA REAGENT KIT

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 FALSELY DECREASED ARCHITECT CEA (CARCINOEMBRYONIC ANTIGEN) RESULT FOR A 52-YEAR-OLD MALE PATIENT FROM THE ONCOLOGY DEPARTMENT. THE SAMPLE WAS REPEATED AND HIGHER RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED: NORMAL REFERENCE RANGE: < 5 NG/ML. SID (B)(6) INITIAL RESULT = < 0.5 NG/ML. REPEAT RESULTS = 11.72, 12.77, 11.99, 12.81 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR FALSELY DECREASED ARCHITECT CEA (CARCINOEMBRYONIC ANTIGEN) RESULT INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, INSTRUMENT LOG REVIEW, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, AND LABELING REVIEW. ADDITIONALLY, IN-HOUSE TESTING OF RETAINED REAGENT KIT WAS ALSO COMPLETED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF THE INSTRUMENT LOGS CONFIRMED SAMPLE ASPIRATION ANOMALIES FOR THE INITIAL TEST AND IT WAS RECOMMENDED THAT THE CUSTOMER SHOULD IMPLEMENT SLOPE MONITORING. A TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. A REVIEW OF THE COMPLAINT TRENDING REPORT DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT 52547FN00 AND COMPLAINT ISSUE. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. PER PRODUCT LABELING, FOR OPTIMAL RESULTS, SPECIMENS SHOULD BE FREE OF FIBRIN, RED BLOOD CELLS, OR OTHER PARTICULATE MATTER; THE PRESENCE OF FIBRIN MAY CAUSE ERRONEOUS RESULTS. ADDITIONALLY, ACCURACY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED REAGENT KIT OF THE COMPLAINT LOT. ALL SPECIFICATIONS WERE MET WHICH INDICATES THE LOT IS PERFORMING AS EXPECTED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED. THE ARCHITECT CEA (CARCINOEMBRYONIC ANTIGEN) REAGENT, LOT NUMBER 52547FN00 IS PERFORMING AS EXPECTED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT CEA (CARCINOEMBRYONIC ANTIGEN) RESULT FOR A 52-YEAR-OLD MALE PATIENT FROM THE ONCOLOGY DEPARTMENT. THE SAMPLE WAS REPEATED AND HIGHER RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED: NORMAL REFERENCE RANGE: < 5 NG/ML SID (B)(6)INITIAL RESULT = < 0.5 NG/ML REPEAT RESULTS = 11.72, 12.77, 11.99, 12.81 NG/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.