ALINITY I CA 19-9XR REAGENT KIT

Additional Manufacturer Narrative

COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION, 1. PATIENT IDENTIFIER = SID= (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P32-30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21/31, WITH 510K/PMA/BLA NUMBER K052000. THE COMPLAINT EVALUATION 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 OF ALINITY I CA 19-9XR REAGENT LOT NUMBER, 66288FP00. THE LOT SEARCH REVIEW DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE ISSUE FOR THE LIKELY CAUSE LOTS 66288FP00. A REVIEW OF TRACKING AND TRENDING DATA DID NOT IDENTIFY ANY RELATED TRENDS FOR THE PRODUCT FOR THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. HISTORICAL PERFORMANCE OF THE ALINITY I CA 19-9XR REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED VIA ABBOTTLINK FROM CUSTOMERS WORLDWIDE. THIS EVALUATION INDICATED THAT MEDIAN PATIENT RESULT FOR THE LOT IS WITHIN ESTABLISHED LIMITS AND COMPARABLE WITH OTHER LOTS IN THE FIELD, CONFIRMING NO SYSTEMIC ISSUE FOR THE LOT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT 66288FP00 AND COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I CA 19-9XR REAGENT LOT NUMBER, 66288FP00.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I CA 19-9XR RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6)2024, SID (B)(6), INITIAL=581.6 U/ML /DIFFERENT SPECIMEN FROM SAME PATIENT REPEATED ON (B)(6)2024=7.6 U/ML /REPEATED ORIGINAL SPECIMEN FROM (B)(6)2024=6.6 U/ML. IT IS UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.