ALINITY I CEA REAGENT KIT

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. ADDITIONAL PATIENT TESTING ADDED TO SECTION B5.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY DECREASED ALINITY I CEA RESULT ON A 68-YR OLD MALE PATIENT DIAGNOSED WITH LUNG CANCER THAT WAS POSITIVE ON OTHER PLATFORMS AND PREVIOUSLY ELEVATED BY ABBOTT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) ABBOTT = 4.25 / 4.38 NG/ML; MINDRAY PLATFORM = 45.52 NG/ML. (B)(6) 2025 ABBOTT = 4.58NG/ML; MINDRAY PLATFORM = 47.06 NG/ML; ROCHE PLATFORM = 40.82 NG/ML; BECKMAN PLATFORM = 29.81 NG/ML. (B)(6) 2025 SID (B)(6) ABBOTT = 11.52 NG/ML; MINDRAY PLATFORM = 51.94 NG/ML. (B)(6) 2025 SID (B)(6) ABBOTT = 10.68 NG/ML; MINDRAY PLATFORM = 16.68 NG/ML. PREVIOUS RESULT ON (B)(6) 2025 ABBOTT = 77.90 NG/ML; MINDRAY PLATFORM = 68.86 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELLING REVIEW, DEVICE HISTORY RECORD REVIEW, FIELD DATA REVIEW AND INHOUSE TESTING OF A RETAINED KIT WITH THE COMPLAINT LOT NUMBER. TRENDING REVIEW DETERMINED NO TRENDS FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT. INHOUSE TESTING DETERMINED THAT THE ACCURACY PERFORMANCE IS NOT NEGATIVELY IMPACTED. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. BASED ON OUR INVESTIGATION, WE HAVE DETERMINED THAT THERE IS NO SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WITH ALINITY I CEA REAGENT LOT 59235FZ00.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY DECREASED ALINITY I CEA RESULT ON A 68-YR OLD MALE PATIENT DIAGNOSED WITH LUNG CANCER THAT WAS POSITIVE ON OTHER PLATFORMS AND PREVIOUSLY ELEVATED BY ABBOTT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) ABBOTT = 4.25 / 4.38 NG/ML; MINDRAY PLATFORM = 45.52 NG/ML (B)(6) 2025 ABBOTT = 4.58NG/ML; MINDRAY PLATFORM = 47.06 NG/ML; ROCHE PLATFORM = 40.82 NG/ML; BECKMAN PLATFORM = 29.81 NG/ML. (B)(6) 2025 SID (B)(6) ABBOTT = 11.52 NG/ML; MINDRAY PLATFORM = 51.94 NG/ML. (B)(6) 2025 SID (B)(6) ABBOTT = 10.68 NG/ML; MINDRAY PLATFORM = 16.68 NG/ML. PREVIOUS RESULT ON (B)(6) 2025 ABBOTT = 77.90 NG/ML; MINDRAY PLATFORM = 68.86 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON A PRODUCT THAT HAS THE SAME PRODUCT DISTRIBUTED IN THE US, WITH 510K/PMA/BLA NUMBER K990774.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY DECREASED ALINITY I CEA RESULT ON A TUMOR PATIENT DIAGNOSED WITH LUNG CANCER THAT WAS POSITIVE ON OTHER PLATFORMS AND PREVIOUSLY ELEVATED BY ABBOTT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 ABBOTT = 4.25NG/ML; MINDRAY PLATFORM = 45.52 NG/ML. (B)(6) 2025 ABBOTT = 4.58NG/ML; MINDRAY PLATFORM = 47.06 NG/ML; ROCHE PLATFORM = 40.82 NG/ML; BECKMAN PLATFORM = 29.81 NG/ML. (B)(6) 2025 ABBOTT = 77.90 NG/ML; MINDRAY PLATFORM = 68.86 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.