COBAS AMPLICOR CT/NG TEST

Description of Event or Problem

A CUSTOMER SITE IN UNITED STATES REPORTED THAT THEY RECEIVED DISCREPANT (B)(6) RESULTS WHEN USING THE COBAS AMPLICOR CT/NG TEST. THE CUSTOMER SITE PROTOCOL IS TO REPEAT TEST ALL (B)(6) RESULTS IN DUPLICATE, WHICH IS AN OFF-LABEL PRACTICE. AS PER PRODUCT LABELING, A VALID RESULT SHOULD BE REPORTED AND ANY ADDITIONAL TESTING SHOULD BE PERFORMED WITH AN ALTERNATE METHOD.. THE ORIGINAL (B)(6) RESULT ON (B)(6) 2013 WAS (B)(6). THE SAMPLE WAS REPEATED ON (B)(6) 2013 AND WAS (B)(6). THE SAMPLE WAS AGAIN REPEATED ON (B)(6) 2013 AND GENERATED A GREY ZONE RESULT. IT IS NOT KNOWN WHAT RESULT WAS REPORTED BY THE CUSTOMER.

Additional Manufacturer Narrative

RESULT - INVESTIGATIVE TESTING REPRODUCED CUSTOMER'S ALLEGATION OF DISCREPANT (B)(6) RESULTS GENERATED. CONCLUSION: OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO EVENT. THE CUSTOMER GENERATED DISCREPANT (B)(6) RESULTS FOR ONE SAMPLE- ONE (B)(6) RESULT, ONE (B)(6) RESULT AND ONE GREY ZONE RESULT. INVESTIGATIVE TESTING FOR THE SAMPLE IN QUESTION WAS RUN IN TRIPLICATE AND GENERATED (B)(6) RESULTS. KIT RETAIN TESTING OF THE COMPLAINT KIT BATCH GENERATED VALID RESULTS THAT MET SPECIFICATION. IT IS POSSIBLE THAT THE CAUSE OF THE DISCREPANT RESULTS IS DUE TO AN UNKNOWN SAMPLE SPECIFIC ISSUE, BUT THIS CANNOT BE DEFINITIVELY CONFIRMED. AS THE RETAIN KIT TESTING MET SPECIFICATION, THERE IS NO INDICATION OF A PRODUCT NON-CONFORMANCE. (B)(4).