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 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. A 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 70451FP00. A REVIEW OF HISTORICAL PERFORMANCE OF REAGENT LOT 70451FP00, USING WORLDWIDE DATA FOR ARCHITECT CA 19-9XR ASSAY. THE PATIENT¿S DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR LOT 70451FP00 IS WITHIN THE ESTABLISHED CONTROL LIMITS. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED FOR 70451FP00. A DEVICE HISTORY RECORD WAS REVIEWED AND DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS FOR THE COMPLAINT LOT. 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 70451FP00 WAS IDENTIFIED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02K91-39 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2K91-33, WITH 510K/PMA/BLA NUMBER K052000. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT CA 19-9XR RESULTS FOR ONE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: INITIAL CA 19-9 RESULT = 71.5 U/ML; REPEAT RESULT = 4.0 U/ML; REPEAT RESULT ALIQUOTED FROM ORIGINAL SAMPLE TUBE = 4.5 U/ML. THE MEASUREMENTS WERE PERFORMED AT A TESTING CENTER; THEREFORE, THE CUSTOMER WAS UNABLE TO OBTAIN PATIENT INFORMATION, AND IT IS NOT KNOWN IF THIS PATIENT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.