ALINITY I CEA REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED DISCREPANT ALINITY I CEA RESULTS FOR A 77-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: JULY RESULT (LOT 36540FN00) = 120.4 NG/ML, AUGUST RESULT (LOT 36543FN00) = 25.58 NG/ML, SEPTEMBER RESULT (LOT 39407FN00) = 79.6 NG/ML, OCTOBER RESULT (LOT 39407FN00) = 22.9 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. INITIAL REPORTER NAME AND ADDRESS (B)(6). INITIAL REPORTER PHONE NUMBER: (B)(6).

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR DISCREPANT (ERRATIC/VARIABLE) ALINITY I CEA (CARCINOEMBRYONIC ANTIGEN) RESULTS 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 IN HOUSE TESTING OF A RETAINED REAGENT KIT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS. THE OVERALL PERFORMANCE OF ALINITY I CEA (CARCINOEMBRYONIC ANTIGEN) REAGENTS IN THE FIELD WAS REVIEWED USING DATA FROM CUSTOMERS WORLDWIDE AND SUGGESTED THAT THE PERFORMANCE IS ACCEPTABLE AND AS EXPECTED. IN-HOUSE RETAINED REAGENT KITS OF THE COMPLAINT LOTS WERE TESTED, AND ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOTS ARE PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I CEA (CARCINOEMBRYONIC ANTIGEN) REAGENT LOTS 36543FN00 WERE IDENTIFIED.