ARCHITECT CYCLOSPORINE REAGENT KIT

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY DEPRESSED ARCHITECT CYCLOSPORINE RESULT FOR ONE PATIENT A 17 YEAR-OLD FEMALE WITH APLASTIC ANEMIA. THE RESULTS WERE LOWER THAN PREVIOUS RESULTS. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 139.4 NG/ML RETEST RESULT = 117.0 NG/ML HISTORICAL TEST RESULTS = FROM (B)(6) 2022 = 217.2 NG/ML FROM (B)(6) 2022 = 187.0 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR A FALSELY DECREASED ARCHITECT CYCLOSPORINE RESULT 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 TESTING OF THE COMPLAINT LOT NUMBER. TRENDING REVIEW DETERMINED NO RELATED TREND FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED, AS RETURNS WERE NOT AVAILABLE. ACCURACY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF LOT 40862FP00. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT AND COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF ARCHITECT CYCLOSPORINE REAGENT, LOT NUMBER 40862FP00, WAS IDENTIFIED.