ALINITY I CA 19-9XR REAGENT KIT

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION 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 SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. THE TICKET TRENDING REVIEW DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. THE OVERALL PERFORMANCE OF THE ALINITY I CA 19-9XR REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN VALUES OBTAINED WITH THE COMPLAINT LOT 71502FP00 IS WITHIN ESTABLISHED LIMITS AND THUS COMPARABLE TO THE HISTORICAL LOT PERFORMANCE, WHICH CONFIRMS NO SYSTEMIC ISSUE FOR THE LOT. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CA 19-9XR REAGENT LOT 71502FP00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED IMPRECISE ALINITY I CA 19-9XR WHEN DILUTION IS REQUIRED AND PROVIDED THE FOLLOWING DATA FOR PATIENTS WHO ARE DIAGNOSED WITH PANCREATIC CANCER AND BEING MONITORED FOR TREATMENT: PATIENT 1 ON (B)(6) 2025, SAMPLE ID (B)(6), RESULTS ARE AS FOLLOWS: ON SN: (B)(6): > 1200.00 U/ML, < 3, 0000.00 (1:100 MANUAL DILUTION), < 3, 0000.00 (1:1000 MANUAL DILUTION), 917.97 (1:10 MANUAL DILUTION), 745.75 (1:10 DILUTION). ON SN: (B)(6): > 1200.00 U/ML, < 3, 0000.00 (1:100 MANUAL DILUTION), < 3, 0000.00 (1:1000 MANUAL DILUTION), 1050.77 (1:10 MANUAL DILUTION), 897.65 (1:10 DILUTION). ON SN: (B)(6): > 1200.00 U/ML, < 3, 0000.00 (1:100 MANUAL DILUTION), < 3, 0000.00 (1:1000 MANUAL DILUTION), 945.46 (1:10 MANUAL DILUTION), 796.51 (1:10 DILUTION). PATIENT 2 ON (B)(6) 2025, SAMPLE ID (B)(6) RESULTS ARE AS FOLLOWS: ON SN: (B)(6): > 1200.00 U/ML, 1878.30 (1:10 DILUTION). ON SN: (B)(6): 1001.15 U/ML (1:10 DILUTION). THE CUSTOMER REPORTED THAT THEY ARE NOT CERTAIN WHICH RESULTS ARE CORRECT. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Description of Event or Problem

THE CUSTOMER REPORTED IMPRECISE ALINITY I CA 19-9XR WHEN DILUTION IS REQUIRED AND PROVIDED THE FOLLOWING DATA FOR PATIENTS WHO ARE DIAGNOSED WITH PANCREATIC CANCER AND BEING MONITORED FOR TREATMENT: PATIENT 1 ON (B)(6) 2025 SAMPLE ID (B)(6) RESULTS ARE AS FOLLOWS: ON SN: (B)(6): > 1200.00 U/ML, < 3, 0000.00 (1:100 MANUAL DILUTION), < 3, 0000.00 (1:1000 MANUAL DILUTION), 917.97 (1:10 MANUAL DILUTION), 745.75 (1:10 DILUTION). ON SN: (B)(6): > 1200.00 U/ML, < 3, 0000.00 (1:100 MANUAL DILUTION), < 3, 0000.00 (1:1000 MANUAL DILUTION), 1050.77 (1:10 MANUAL DILUTION), 897.65 (1:10 DILUTION). ON SN: (B)(6): > 1200.00 U/ML, < 3, 0000.00 (1:100 MANUAL DILUTION), < 3, 0000.00 (1:1000 MANUAL DILUTION), 945.46 (1:10 MANUAL DILUTION), 796.51 (1:10 DILUTION). PATIENT 2 ON (B)(6) 2025, SAMPLE ID (B)(6) RESULTS ARE AS FOLLOWS: ON SN: (B)(6): > 1200.00 U/ML, 1878.30 (1:10 DILUTION). ON SN: (B)(6): 1001.15 U/ML (1:10 DILUTION). THE CUSTOMER REPORTED THAT THEY ARE NOT CERTAIN WHICH RESULTS ARE CORRECT. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

A1 PATIENT IDENTIFIER: COMPLETE LIST OF SAMPLE ID'S ARE (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P32-30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21 / 31, WITH 510K/PMA/BLA NUMBER K052000. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.