ARCHITECT CEA

Additional Manufacturer Narrative

UPDATE: PATIENT AND DEVICE CODES WERE PROVIDED.

Additional Manufacturer Narrative

FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, IN-HOUSE TESTING, REVIEW OF MANUFACTURING DOCUMENTATION AND REVIEW OF LABELING. THE CUSTOMER'S INSTRUMENT LOGS WERE REVIEWED. NO INSTRUMENT ERRORS WERE ASSOCIATED WITH THE DEPRESSED CEA TEST RESULT; HOWEVER, THE SAMPLE WAS SIMULTANEOUSLY BEING TESTED FOR CA19-9 WHERE A SAMPLE ASPIRATION ERROR WAS GENERATED. THE SAMPLE WAS SUBSEQUENTLY RETESTED FOR CEA AND RETURNED RESULTS WHICH WERE MORE CONSISTENT WITH PREVIOUS RESULTS FROM THIS PATIENT. FURTHER REVIEW OF INSTRUMENT LOGS ALSO INDICATED A LOW PRESSURE DISCORD VALUE DURING THE TESTING OF THE CA19-9 REPLICATE WHICH RETURNED THE ASPIRATION ERROR. THE PRESSURE DISCORD VALUE FOR THE DEPRESSED CEA REPLICATE WAS ACCEPTABLE, BUT WAS LOW COMPARED TO THE RETEST REPLICATES. THE CUSTOMER INDICATED THAT THEY DID NOT CHECK THE SAMPLE FOR THE PRESENCE OF BUBBLES. IT WAS RECOMMENDED THAT THE CUSTOMER ENABLING SLOPE SCORE ON THEIR INSTRUMENT, WHICH SHOULD REDUCE ABERRANT VALUES DUE TO SAMPLE PREPARATION/QUALITY ISSUES. THE TICKET SEARCHES DETERMINED THAT THERE IS NO UNUSUAL ACTIVITY FOR THE LIKELY CAUSE LOT 72324FN00. COMPLAINT TRENDING REPORT REVIEW DETERMINED THAT THERE IS NO NON-STATISTICAL OR ADVERSE TRENDS RELATED TO THE CUSTOMER'S ISSUE FOR THE ARCHITECT CEA ASSAY. SINCE NO PATIENT SAMPLE WAS AVAILABLE TO ASSIST IN THE INVESTIGATION, ACCURACY TESTING WAS PERFORMED USING A CEA SERUM BASED PANEL WHICH MIMICS PATIENT SAMPLES AND IS CLOSEST IN CONCENTRATION TO THE CUSTOMERS EXPECTED RESULTS. ACCURACY TESTING WAS COMPLETED USING AN IN-HOUSE RETAINED KIT STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER OBSERVATION. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. USING WORLD WIDE FIELD DATA FOR THE ARCHITECT CEA ASSAY, THE PERFORMANCE OF REAGENT LOT 72324FN00 WAS COMPARED TO THE PERFORMANCE OF ALL ARCHITECT CEA LOTS USED IN THE FIELD IN THE LAST TWELVE MONTHS. THIS REVIEW INDICATES THAT LOT 72324FN00 IS PERFORMING SIMILAR TO OTHER REAGENT LOTS IN THE FIELD. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT ANTI-HCV ASSAY WAS IDENTIFIED.

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 REPORTED THEY OBTAINED A FALSE DEPRESSED RESULT ON THE ARCHITECT CEA ASSAY WITH REAGENT LOT 72324FN00. SAMPLE ID (B)(6) GENERATED AN INITIAL RESULT OF 3.35 NG/ML AND WHEN REPEATED IN DUPLICATE (SAMPLE ID (B)(6)) GENERATED 149.00 AND 142.16 NG/ML.