ARCHITECT CYCLOSPORINE REAGENT KIT

Additional Manufacturer Narrative

A1 PATIENT IDENTIFIER: COMPLETE SAMPLE ID IS (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 03R30-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 1L75, WITH 510K/PMA/BLA NUMBER K080751. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT CYCLOSPORINE. THE CUSTOMER PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, SAMPLE ID: (B)(6) WAS TESTED WITH AN UPGRADED CYCLOA REAGENT, THE RESULT WAS 113.6NG/ML. WHEN THE SAMPLE WAS RETESTED, THE RESULT WAS 120.1NG/ML, HISTORICAL RESULTS: ON (B)(6), 2025, WHEN TESTED USING THE CYCLO REAGENT THAT HAD NOT BEEN UPGRADED, THE RESULT WAS 190.4NG/ML. ON (B)(6) 2025, WHEN TESTED USING THE CYCLO REAGENT THAT HAD NOT BEEN UPGRADED, THE RESULT WAS 213.8NG/ML. PATIENT DATA: BONE MARROW TRANSPLANT PATIENT SINCE (B)(6) 2025. THE CUSTOMER CONFIRMED THAT THERE WERE NO RECENT ADJUSTMENTS IN DRUG DOSES. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

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, IN HOUSE TESTING AND LABELING REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER CONFIRMS THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT CYCLOSPORINE ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY REGARDING COMMONALITIES FOR COMPLAINT LOT AND ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 73066FZ01. A DEVICE HISTORY RECORD REVIEW SYSTEM DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER AND COMPLAINT ISSUE. IN HOUSE ACCURACY TESTING WAS PERFORMED USING A RETAINED KIT OF THE COMPLAINT LOT. ALL ACCEPTANCE CRITERIA WERE MET AND THE PRODUCT IS PERFORMING AS EXPECTED. A REVIEW OF THE LABELLING ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CYCLOSPORINE REAGENT LOT 73066FZ01 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT CYCLOSPORINE. THE CUSTOMER PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, SAMPLE ID: (B)(6) WAS TESTED WITH AN UPGRADED CYCLOA REAGENT, THE RESULT WAS 113.6NG/ML. WHEN THE SAMPLE WAS RETESTED, THE RESULT WAS 120.1NG/ML, HISTORICAL RESULTS: ON (B)(6) 2025, WHEN TESTED USING THE CYCLO REAGENT THAT HAD NOT BEEN UPGRADED, THE RESULT WAS 190.4NG/ML. ON (B)(6) 2025, WHEN TESTED USING THE CYCLO REAGENT THAT HAD NOT BEEN UPGRADED, THE RESULT WAS 213.8NG/ML. PATIENT DATA: BONE MARROW TRANSPLANT PATIENT SINCE (B)(6) 2025. THE CUSTOMER CONFIRMED THAT THERE WERE NO RECENT ADJUSTMENTS IN DRUG DOSES. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.