ARCHITECT CEA REAGENT KIT

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW AND FIELD DATA REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE LIKELY CAUSE LOT OR COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS FOR THE LIKELY CAUSE LOT. THE OVERALL PERFORMANCE OF ARCHITECT CEA REAGENT IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE MEDIAN PATIENT POPULATION RESULT FOR LOT 26467FN00 IS COMPARABLE WITH ALL OTHER LOTS IN THE FIELD AND WITHIN ESTABLISHED BASELINES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ARCHITECT CEA REAGENT LOT 26467FN00 WAS IDENTIFIED.

Additional Manufacturer Narrative

PATIENT IDENTIFIER: (B)(6). 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 DEPRESSED ARCHITECT CEA RESULTS GENERATED ON AN ARCHITECT I2000 PROCESSING MODULE ON A (B)(6) MALE UNDERGOING RADIATION THERAPY FOR LUNG CANCER. THE FOLLOWING RESULTS WERE PROVIDED. SID (B)(6) INITIAL RESULT = 1.47 NG/ML, REPEAT RESULT = 32.63 NG/ML. THE PATIENT HAD BEEN TRENDING AROUND 30 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.