ARCHITECT CYCLOSPORINE REAGENT KIT

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR FALSELY DEPRESSED ARCHITECT CYCLOSPORINE RESULTS 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. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT 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 69565FZ01. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LOT NUMBER AND COMPLAINT ISSUE. IN HOUSE ACCURACY TESTING MET ACCEPTANCE CRITERIA AND THE PRODUCT IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ARCHITECT CYCLOSPORINE REAGENT KIT FOR LOT NUMBER 69565FZ01 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT CYCLOSPORINE RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL RESULT = <6.7 NG/ML, REPEAT RESULT = <6.7 NG/ML THE PATIENT'S HISTORICAL RESULT WAS 500.3 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. 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 ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT CYCLOSPORINE RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL RESULT = <6.7 NG/ML, REPEAT RESULT = <6.7 NG/ML THE PATIENT'S HISTORICAL RESULT WAS 500.3 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THIS FOLLOW UP SUBMISSION SEND TO UPDATE SECTION H6: ADVERSE EVENT PROBLEM: MEDICAL DEVICE PROBLEM CODE TO A090810 FROM A090809.