COBAS TAQSCREEN MPX TEST

Additional Manufacturer Narrative

A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME, AS THE INVESTIGATION INTO THIS ISSUE IS ONGOING. THE OUTCOME OF THE INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. THE ASSOCIATED US KIT IS M/N 04584252190 BL 125255. (B)(4).

Additional Manufacturer Narrative

(B)(4). NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION. THE CUSTOMER ALLEGED FALSE (B)(6) RESULTS WERE GENERATED FOR SAMPLES COLLECTED FROM ONE DONOR WHEN TESTED WITH THE COBAS TAQSCREEN MPX TEST. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT NON-CONFORMANCE. THE SAMPLE FROM THE SECOND DONATION, WHICH WAS FOUND TO BE SEROLOGICALLY (B)(6), WAS SUBMITTED FOR SEQUENCING ANALYSIS. HOWEVER, NO (B)(6) SEQUENCE WAS OBTAINED FROM THIS SAMPLE, SO IT CANNOT BE DETERMINED IF MISMATCHES TO THE ASSAY (B)(4) ACCOUNTED FOR THE (B)(6) RESULTS WITH THE COBAS TAQSCREEN MPX TEST. IN ADDITION, THIS DOES NOT NECESSARILY MEAN THAT THERE IS NO (B)(6) PRESENT IN THE SAMPLE, AS THE LACK OF VIRAL SEQUENCE INFORMATION COULD BE DUE TO SEQUENCE HETEROGENEITY UNDER THE PRIMERS USED FOR SEQUENCING AND / OR DUE TO LOW VIRAL TITERS. THE SAMPLE WAS ALSO TESTED WITH THE CAP/CTM HCV TEST TO DETERMINE IF AN HCV TITER COULD BE GENERATED. THIS TESTING GENERATED A RESULT OF "TARGET NOT DETECTED" (TND) FOR THE SAMPLE, INDICATING THAT THE SAMPLE DID NOT CONTAIN AN (B)(4) VIRAL LOAD ABOVE THE LIMIT OF DETECTION (LOD) OF THE CAP/CTM HCV TEST OF (B)(6). THE DONOR SAMPLES (FOUR COLLECTIONS) GENERATED VARYING RESULTS WITH SEROLOGY AND PCR TESTING. IN ADDITION, THE TND RESULT OBTAINED WITH THE CAP/CTM HCV TEST INDICATE THAT IT IS LIKELY THAT THE DONOR SAMPLES HAVE A (B)(6), AT OR BELOW THE LOD OF THE COBAS TAQSCREEN MPX TEST. (B)(4).

Description of Event or Problem

A CUSTOMER IN (B)(6) HAD FILED A COMPLAINT IN 2010 ALLEGING DISCREPANT RESULTS FOR DONOR SAMPLES BETWEEN THE COBAS TAQSCREEN MPX TEST, CE-IVD AND SEROLOGY TESTING WITH DIASORIN A-HCV VERSION 4.0 TEST. THE CUSTOMER HAD COLLECTED DATA FOR THE YEAR 2010, IN WHICH MULTIPLE SAMPLES WERE IDENTIFIED TO HAVE GENERATED DISCREPANT RESULTS. IN THAT CASE, THERE WAS NO REPEAT TESTING PERFORMED AT THAT TIME WITH THE COBAS TAQSCREEN MPX TEST, CE-IVD FOR ANY OF THE SAMPLES, AS THE SAMPLES WERE NOT AVAILABLE FOR INVESTIGATIVE TESTING AT THE TIME. ONLY SEROLOGY TESTING WAS REPEATED WHICH REPRODUCED THE INITIAL SEROLOGY (B)(6) RESULTS. NO PRODUCT NON-CONFORMANCE WAS IDENTIFIED IN INVESTIGATION OF THAT COMPLAINT. AS PART OF THE CUSTOMER'S INTERNAL INVESTIGATION, ONE OF THE SAMPLES FROM THE SAME COLLECTION THAT WAS RUN IN A POOL OF 6 WITH THE COBAS TAQSCREEN MPX TEST, CE-IVD ON (B)(6) 2010 AND GENERATED A NON-REACTIVE RESULT WAS RETESTED ON (B)(6) 2011 WITH THE COBAS AMPLICOR HCV QUAL TEST, V2.0 AND GENERATED A (B)(6) RESULT AND (B)(6) GENERATED AN UNDERMINED RESULT. THE SAMPLES ARE BEING SENT FOR SEQUENCING.