ELECSYS ANTI-CCP IMMUNOASSAY

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).

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. THE EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THIS EVENT WAS PREVIOUSLY REPORTED TO FDA AS A VOLUNTARY MALFUNCTION SUMMARY REPORT, SUBMISSION NUMBER 1823260-2019-90146. THE EVENT IS NOW BEING REPORTED AS AN INDIVIDUAL MDR DUE TO AN ANTICIPATED RECALL OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE FILED WITH THE RECALL NUMBER WHEN THE RECALL IS FILED WITH FDA. THE INITIAL REPORTER COMPLAINED OF A NON-REPRODUCIBLE ELECSYS ANTI-CCP IMMUNOASSAY RESULTS FOR 3 PATIENT SAMPLES TESTED ON A COBAS 8000 E 602 MODULE SERIAL NUMBER (B)(4). FOR PATIENT 1 THE INITIAL RESULT WAS 45.98 U/ML. THE SAMPLE WAS REPEATED AND THE RESULT WAS 28.17 U/ML. THE SAMPLE WAS REPEATED A THIRD TIME AND THE RESULT WAS 12.25 U/ML. FOR PATIENT 2 THE INITIAL RESULT WAS 36.34 U/ML. THE SAMPLE WAS REPEATED AND THE RESULT WAS 24.14 U/ML. THE SAMPLE WAS REPEATED A THIRD TIME AND THE RESULT WAS 8.93 U/ML. THE PATIENT WAS A (B)(6) FEMALE. FOR PATIENT 3 THE INITIAL RESULT WAS 41.39 U/ML. THE SAMPLE WAS REPEATED AND THE RESULT WAS 23.50 U/ML. THE SAMPLE WAS REPEATED A THIRD TIME AND THE RESULT WAS 11.41 U/ML. THE PATIENT WAS A (B)(6) MALE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.