VERSANT 440 MOLECULAR SYSTEM

Description of Event or Problem

AN OPERATOR NOTED GREATER THAN EXPECTED USE OF CLEANING SOLUTION AND LESS THAN EXPECTED USE OF A WASH A WHILE RUNNING THE VERSANT HIV-1 RNA 3.0 ASSAY ON THE VERSANT 440 MOLECULAR SYSTEM. A FIELD SERVICE ENGINEER DETERMINED THAT THE LINES HAD BEEN SWITCHED DURING ROUTINE SERVICE OF THE INSTRUMENT. TWO (B)(6) AND ONE (B)(6) RUNS WERE PERFORMED USING CLEANING SOLUTION RATHER THAN WASH BUFFER FOR ASSAY WITH WASH STEPS. RLUS WERE LOWER THAN NORMAL BUT CONTROLS WERE WITHIN ACCEPTABLE LIMITS FOR THE ASSAYS AND RESULT WERE REPORTED. (B)(6) RUNS WERE REPEATED AFTER THE WASH LINE ERROR WAS CORRECTED. SEVEN (B)(6) SAMPLES RE-TESTED SHOWED DISCREPANCIES; OF THE SEVEN, TWO SAMPLES SHOWED CLINICALLY SIGNIFICANT DIFFERENCES (3 FOLD CHANGE). (B)(6) RESULTS DID NOT SHOW ANY SIGNIFICANT DISCREPANCIES UPON RE-TESTING. THE RESULTS INITIALLY REPORTED FOR THE (B)(6) SAMPLES SHOWING A 3 FOLD DISCREPANCY WERE 233 AND 236 COPIES PER ML. THE REPEAT TESTING INDICATED THAT BOTH WERE LESS THAN 75 COPIES/ML. CORRECTED REPORTS WERE ISSUED FOR ALL SEVEN SAMPLES. TESTING IS UNDERWAY TO CONFIRM THE PERFORMANCE OF THE ASSAY UNDER THE FAULT CONDITIONS REPORTED.

Additional Manufacturer Narrative

ON (B)(4), 2009, A FIELD SERVICE ENGINEER WENT TO THE CUSTOMER SITE TO CONFIRM FLUIDICS PERFORMANCE ON THE VERSANT 440 MOLECULAR SYSTEM AND FOUND THAT THE WASH A LINE HAD BEEN REVERSED WITH THE CLEANING SOLUTION LINE. THIS WAS TRACED TO AN INSTRUMENT SERVICE PERFORMED ON (B)(4) 2009 WHEN THE LINES HAD BEEN REPLACED. THE PROBLEM WAS CORRECTED BY THE FIELD SERVICE ENGINEER.