ALINITY I CA 19-9XR REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED ERRATIC ALINITY I CA 19-9XR FOR ONE PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6)2024, SID (B)(6), INITIAL CA 19-9 RESULT= 30.50 U/ML; REPEAT RESULTS= 4.69 U/ML AND 6.89 U/ML IT IS UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

SECTION H6 - ADVERSE EVENT PROBLEM, MEDICAL DEVICE PROBLEM CODE WAS UPDATED. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, FIELD DATA REVIEW AND LABELING 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. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY TRENDS FOR LIST NUMBER 08P32; HOWEVER, AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 66298FP00 WAS NOT IDENTIFIED. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES, NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH LOT 66298FP00 AND COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF THE ALINITY I CA 19-9XR REAGENT WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE. REVIEW OF THE DATA ASSOCIATED WITH REAGENT LOT 66298FP00 INDICATE THE PATIENT MEDIANS ARE WITHIN THE ESTABLISHED LIMITS. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED FOR LOT 66298FP00. 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 LOT 66298FP00 WAS IDENTIFIED.

Additional Manufacturer Narrative

COMPLETE ENTRY FOR SECTION A1 - PATIENT IDENTIFIER: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P32-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P32-21/31, WITH 510K/PMA/BLA NUMBER K052000. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED ERRATIC ALINITY I CA 19-9XR FOR ONE PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2024, SID (B)(6), INITIAL CA 19-9 RESULT= 30.50 U/ML; REPEAT RESULTS= 4.69 U/ML AND 6.89 U/ML IT IS UNKNOWN IF THE PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.