ALINITY I CA 19-9XR REAGENT KIT

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, A TICKET TRENDING REVIEW, A DEVICE HISTORY RECORD REVIEW, A FIELD DATA REVIEW, AND A LABELING REVIEW. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A 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 71503FP00. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT 71503FP00 AND THE COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF ALINITY I CA 19-9XR REAGENTS 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 71503FP00 IS WITHIN THE ESTABLISHED CONTROL LIMITS. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED FOR 71503FP00. IN THIS CASE, THE PATIENT RESULTS OBTAINED ON THE ALINITY WERE BEING COMPARED AGAINST PATIENT RESULTS FROM ANOTHER METHOD, AND PER THE PACKAGE INSERT, THIS IS NOT ALLOWED. IN ADDITION, THE POOR DILUTION RESULTS AND THE LOWER PEG-TREATMENT RESULT INDICATE A POSSIBLE SAMPLE INTEGRITY ISSUE. BASED ON THE INVESTIGATION, ALINITY I CA 19-9XR, LOT 71503FP00 IS PERFORMING AS INTENDED. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CA 19-9XR REAGENT WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I CA 19-9XR RESULTS GENERATED BY THE ALINITY I PROCESSING MODULE FOR A PANCREATIC CANCER PATIENT UNDERGOING CHEMOTHERAPY. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025: ALINITY I CA 19-9XR RESULT: >1200 U/ML; DILUTED RETEST: 802.66 U/ML (REFERENCE RANGE: 0 TO 37 U/ML) ROCHE CA199 RESULT: 637 U/ML (REFERENCE RANGE: 0 TO 27 U/ML). POST-PEG RESULT: 767.42 U/ML; REDUCED RESULT: 1534.84 U/ML. DILUTION VERIFICATION RESULTS (SAME SAMPLE): ¿ UNDILUTED: >1200 U/ML. ¿ 1:10 AUTOMATIC DILUTION: 1131.98 U/ML. ¿ 2X MANUAL DILUTION: 1278.75 U/ML. ¿ 10X MANUAL DILUTION: 1134.40 U/ML. HISTORICAL RESULTS: (B)(6) 2025: ALINITY: >1200 U/ML, ROCHE: 883 U/ML. (B)(6) 2025: ALINITY: 983 U/ML, ROCHE: 679 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER: 08P32-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 8P32-21, WITH 510K/PMA/BLA NUMBER: K052000. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I CA 19-9XR RESULTS GENERATED BY THE ALINITY I AM PROCESSING MODULE FOR A PANCREATIC CANCER PATIENT UNDERGOING CHEMOTHERAPY. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025: ALINITY I CA 19-9XR RESULT: >1200 U/ML; DILUTED RETEST: 802.66 U/ML (REFERENCE RANGE: 0 TO 37 U/ML) ROCHE CA199 RESULT: 637 U/ML (REFERENCE RANGE: 0 TO 27 U/ML). POST-PEG RESULT: 767.42 U/ML; REDUCED RESULT: 1534.84 U/ML. DILUTION VERIFICATION RESULTS (SAME SAMPLE): UNDILUTED: >1200 U/ML, 1:10 AUTOMATIC DILUTION: 1131.98 U/ML, 2X MANUAL DILUTION: 1278.75 U/ML, 10X MANUAL DILUTION: 1134.40 U/ML. HISTORICAL RESULTS: ON (B)(6) 2025: ALINITY: >1200 U/ML, ROCHE: 883 U/ML. ON (B)(6) 2025: ALINITY: 983 U/ML, ROCHE: 679 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.