ALINITY I CEA REAGENT KIT

Additional Manufacturer Narrative

SECTION A1 PATIENT IDENTIFIER COMPLETE INFORMATION: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P62 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P62, 510K K990774. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I CEA RESULTS FOR A 54-YEAR-OLD FEMALE PATIENT 54-YEAR-OLD CLINICALLY DIAGNOSED WITH A MALIGNANT TUMOR OF THE RIGHT BREAST. THE FOLLOWING RESULTS WERE PROVIDED: (REFERENCE RANGE OF <5 NG/ML) SID (B)(6) INITIAL RESULT = 42.11 NG/ML, REPEAT RESULT = 42.05 NG/ML RESULT WITH 1:10 DILUTION = 235.63 NG/ML AND DILUTION RESULT AFTER PEG = 275.39 NG/ML, THE CUSTOMER BELIEVES THE RESULT OF 275.39 NG/ML IS CORRECT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.