ALINITY I CA 19-9XR REAGENT KIT

Additional Manufacturer Narrative

CORRECTION: SECTION H11: TYPOGRAPHICAL ERROR IN THE PRODUCT EVALUATION, SEE CORRECTED PRODUCT EVALUATION: THE COMPLAINT INVESTIGATION FOR IMPRECISE ALINITY I CA 19-9XR 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 FIELD DATA REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORTED THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I CA 19-9XR ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 71456FP00. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, DEVIATIONS, OR POTENTIAL NON-CONFORMANCES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE.THE OVERALL PERFORMANCE OF ALINITY I CA 19-9XR WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE. THE PATIENT¿S DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR LOT 71456FP00 IS WITHIN THE ESTABLISHED CONTROL LIMITS, THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED FOR 71456FP00. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I CA 19-9XR ASSAY FOR LOT 71456FP00 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED IMPRECISE ALINITY I CA 19-9XR RESULTS FOR ONE PATIENT. THE CUSTOMER OBSERVED A DIFFERENCE IN THE INITIAL TEST AND DILUTED RETEST RESULTS. THE CUSTOMER REPORTED BOTH SAMPLE IDS ARE FOR THE SAME PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) INITIAL RESULT = 1375.368 U/ML, REPEAT RESULT WITH AUTOMATIC DILUTION = 779.982 U/ML, SID (B)(6) 1188.324 U/ML, RESULT WITH AUTOMATIC DILUTION = 603.267 U/ML . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Description of Event or Problem

THE CUSTOMER OBSERVED IMPRECISE ALINITY I CA 19-9XR RESULTS FOR ONE PATIENT. THE CUSTOMER OBSERVED A DIFFERENCE IN THE INITIAL TEST AND DILUTED RETEST RESULTS. THE CUSTOMER REPORTED BOTH SAMPLE IDS ARE FOR THE SAME PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) INITIAL RESULT = 1375.368 U/ML, REPEAT RESULT WITH AUTOMATIC DILUTION = 779.982. U/ML, SID (B)(6) 1188.324 U/ML, RESULT WITH AUTOMATIC DILUTION = 603.267 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR IMPRECISE ALINITY I CA 19-9XR 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 FIELD DATA REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORTED THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I CA 19-9XR ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 71456FP00. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, DEVIATIONS, OR POTENTIAL NON-CONFORMANCES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. TESTING WAS PERFORMED TO EVALUATE THE PERFORMANCE OF THE REAGENT LOT 71456FP00. THE OVERALL PERFORMANCE OF ALINITY I CA 19-9XR WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE. THE PATIENT¿S DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR LOT 71456FP00 IS WITHIN THE ESTABLISHED CONTROL LIMITS, THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED FOR 71456FP00. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I CA 19-9XR ASSAY FOR LOT 71456FP00 WAS IDENTIFIED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P32-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21 WITH 510K/PMA/BLA NUMBER K052000 ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.