ARCHITECT CYCLOSPORINE REAGENT KIT

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR A FALSELY ELEVATED 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. A REVIEW OF TRACKING AND TRENDING FOR THE PRODUCT AND THE LIKELY CAUSE LOT DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. RETURN TESTING WAS NOT COMPLETED, AS RETURNS WERE NOT AVAILABLE. ACCURACY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF LOT 66278FP00, STORED AT THE RECOMMENDED STORAGE CONDITION. 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 66278FP00, WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT CYCLOSPORINE RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT WAS 115.0, REPEAT RESULT WAS 183.1 NG/ML. 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.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT CYCLOSPORINE RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT WAS 115.0, REPEAT RESULT WAS 183.1 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.