ARCHITECT CYCLOSPORINE REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED IMPRECISE ARCHITECT CYCLOSPORINE RESULTS GENERATED ON THE ARCHITECT I2000SR ANALYZER FOR ONE PATIENT. THE CLINICAL PHYSICIAN ADMINISTERED THE DRUG EXPECTING TO YIELD A RESULT AROUND 600 NG/ML. THE PHYSICIAN NOTED THE RESULTS OBTAINED WERE TOO LOW AND TOO HIGH. THE FOLLOWING RESULT DATA WAS PROVIDED: (B)(6) 2025 AT 12:06, SID (B)(6) = 117.38 NG/ML. (B)(6) 2025 AT 12:01, SID (B)(6) = 1028.13 NG/ML. (B)(6) 2025 AT 11:40, SID (B)(6) = 124.83 NG/ML. CONTROLS WERE RUN EACH DAY PRIOR TO TESTING AND WERE WITHIN RANGE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

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. 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 CYCLOSPORINE 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 67637FZ00. ACCURACY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF THE COMPLAINT LOT. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE CURRENT ISSUE. IN THIS CASE, IT WAS NOTED THAT THE RESULTS WERE FLAGGED WITH AN EXCEPTION "EXP" AS THE PRODUCT WAS USED WHEN THE REAGENT'S INSTALLATION STABILITY PERIOD EXPIRED. BASED ON THE INVESTIGATION, ARCHITECT CYCLOSPORINE REAGENT LOT 67637FZ00 IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. A1 - PATIENT IDENTIFIER: (B)(6) (SAME PATIENT BUT 3 DIFFERENT BLOOD COLLECTIONS) ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 3R30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 1L75, WITH 510K/PMA/BLA NUMBER K080751.

Description of Event or Problem

THE CUSTOMER OBSERVED IMPRECISE ARCHITECT CYCLOSPORINE RESULTS GENERATED ON THE ARCHITECT I2000SR ANALYZER FOR ONE PATIENT. THE CLINICAL PHYSICIAN ADMINISTERED THE DRUG EXPECTING TO YIELD A RESULT AROUND 600 NG/ML. THE PHYSICIAN NOTED THE RESULTS OBTAINED WERE TOO LOW AND TOO HIGH. THE FOLLOWING RESULT DATA WAS PROVIDED: (B)(6) 2025 AT 12:06, SID (B)(6) = 117.38 NG/ML (B)(6) 2025 AT 12:01, SID (B)(6) = 1028.13 NG/ML (B)(6) 2025 AT 11:40, SID (B)(6) = 124.83 NG/ML. CONTROLS WERE RUN EACH DAY PRIOR TO TESTING AND WERE WITHIN RANGE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.