ARCHITECT CA19-9XR 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 IN-HOUSE TESTING WAS COMPLETED. 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. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT 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 68327FP00. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH COMPLAINT LOT 68327FP00. ACCURACY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF THE COMPLAINT LOT. ACCEPTANCE CRITERIA WAS MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ARCHITECT CA 19-9XR REAGENT LOT 68327FP00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT CA 19-9XR RESULT FOR ONE PATIENT. IT IS NOT KNOWN IF THE PATIENT HAD BEEN DIAGNOSED WITH PANCREATIC CANCER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL RESULT = 72.32 U/ML. SAMPLE RUN ON ANOTHER INSTRUMENT ((B)(6)). SID (B)(6) RESULT = 47.32 U/ML (THIS RESULT IS CONSIDERED CORRECT). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT CA 19-9XR RESULT FOR ONE PATIENT. IT IS NOT KNOWN IF THE PATIENT HAD BEEN DIAGNOSED WITH PANCREATIC CANCER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL RESULT = 72.32 U/ML. SAMPLE RUN ON ANOTHER INSTRUMENT (B)(6). SID (B)(6) RESULT = 47.32 U/ML (THIS RESULT IS CONSIDERED CORRECT). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 2K91-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2K91-33, WITH 510K/PMA/BLA NUMBER K052000.