THE CUSTOMER REPORTS A FALSELY DECREASED ARCHITECT CYCLOSPORINE ASSAY RESULT FOR ONE PATIENT SAMPLE TESTED ON THE ARCHITECT 12000SR ANALYZER. THE CUSTOMER PROVIDED THE FOLLOWING INFORMATION: (B)(6) 2013: A RESULT OF 1250 NG/ML WAS GENERATED ONE HOUR AFTER DRUG ADMINISTRATION; (B)(6) 2013: A RESULT OF 612 NG/ML WAS GENERATED ONE HOUR AFTER DRUG ADMINISTRATION; (B)(6) 2013: A RESULT OF 146 NG/ML WAS GENERATED ONE HOUR AFTER DRUG ADMINISTRATION; AND, (B)(6) 2013: A RESULT OF GREATER THAN 1500 NG/ML WAS GENERATED ONE HOUR AFTER DRUG ADMINISTRATION. THE CUSTOMER CLAIMS THAT THE (B)(6) 2013 RESULT OF 146 NG/ML IS FALSELY DECREASED. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
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Patient 1
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).
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Patient 1
ACCURACY TESTING WAS PERFORMED TO EVALUATE THE PERFORMANCE OF REAGENT LOT 22639M500 . TESTING WAS PERFORMED USING RETAINED KITS OF THE REAGENT LOT AND TWO INTERNAL CYCLOSPORINE PANELS, WHICH CONSIST OF EDTA HUMAN WHOLE BLOOD CONTAINING CYCLOSPORINE HUMAN PATIENT SAMPLES. ALL REPLICATES OF THE CYCLOSPORINE PANELS WERE WITHIN SPECIFICATION, WHICH DEMONSTRATES THAT THE ASSAY CAN ACCURATELY DETECT A KNOWN CONCENTRATION OF CYCLOSPORINE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT CYCLOSPORINE PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER CONCERN. BASED ON THE RESULTS OF THE CURRENT EVALUATION, THE ARCHITECT CYCLOSPORINE REAGENT KIT, LOT 22639M500, IS PERFORMING AS INTENDED. A PRODUCT MALFUNCTION WAS NOT IDENTIFIED.