ELECSYS ANTI-CCP IMMUNOASSAY

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6). THE CUSTOMER IS NOT HAVING ISSUES WITH ANY OTHER ASSAYS. INSTRUMENT PERFORMANCE TESTING RESULTS WERE ACCEPTABLE.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS ANTI-CCP IMMUNOASSAY (ANTI-CCP) ON A COBAS 6000 E 601 MODULE. THE INITIAL ANTI-CCP RESULT WAS 52.64 U/ML. THE CUSTOMER REPEATED THE SAMPLE 19 TIMES UNTIL THE RESULT WAS < 7.0 U/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E601 MODULE SERIAL NUMBER WAS (B)(4).

Additional Manufacturer Narrative

THE FOLLOWING INFORMATION HAS BEEN COMMUNICATED TO ROCHE CUSTOMERS: ROCHE HAS CONFIRMED PERFORMANCE ISSUES WITH CERTAIN LOTS OF THE ELECSYS ANTI-CCP ASSAY ON THE COBAS E 411 ANALYZER; MODULAR ANALYTICS E 170 MODULE; AND COBAS E 601, 602, AND 801 MODULES WITH PLASMA SAMPLES. THE FOLLOWING CUSTOMER OBSERVATIONS HAVE BEEN REPORTED: 1. DISCREPANT RESULTS BETWEEN SERUM AND PLASMA SAMPLES FROM THE SAME BLOOD DRAW OF A GIVEN PATIENT: NEGATIVE RESULTS (< CUTOFF) ON SERUM AND POSITIVE RESULTS ON PLASMA SAMPLES. 2. DISCREPANT CONCENTRATIONS OBTAINED ON PLASMA SAMPLES WHEN COMPARING DIFFERENT REAGENT LOTS. SERUM SAMPLES ARE NOT AFFECTED AND DO NOT REQUIRE A WORKAROUND. IT IS STRONGLY ADVISED TO USE THE ELECSYS ANTI-CCP ASSAY WITH SERUM SAMPLES ONLY FOR THE AFFECTED LOTS. ROCHE IS CONDUCTING AN INVESTIGATION INTO THE REPORTED ISSUE AND HAS DETERMINED THAT THE ELECSYS ANTI-CCP ASSAY IS STRONGLY AFFECTED BY PRE-ANALYTICAL ERRORS. THE INVESTIGATION HAS REPRODUCED THESE FINDINGS WHEN REQUIREMENTS FOR PRE-ANALYTICAL SAMPLE HANDLING HAVE NOT BEEN MET FOR PLASMA SAMPLES. THEREFORE, WE WOULD LIKE TO EMPHASIZE THE IMPORTANCE OF FOLLOWING THE PRE-ANALYTICAL SAMPLE HANDLING RECOMMENDATIONS WHEN PROCESSING SAMPLES (SERUM AND PLASMA).