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

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF HIGH RESULTS FOR MULTIPLE PATIENTS TESTED FOR ELECSYS ANTI-CCP IMMUNOASSAY (ANTI-CCP) ON A COBAS 8000 E 602 MODULE. IN (B)(6) 2019 THE CUSTOMER BEGAN TO USE ANTI-CCP REAGENT LOT 368033 AND NOTICED AN ABRUPT CHANGE IN THE RESULTS. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE RHEUMATOLOGISTS COMPLAINED OF A HIGHER THAN NORMAL "POSITIVE" RATE AND THE RESULTS DID NOT CORRESPOND TO THE CLINICAL CONDITION FOR THE AFFECTED PATIENT. AFTER (B)(6) 2019 THE CUSTOMER NOTICED THAT INSTEAD OF GETTING "MOSTLY" RESULTS OF < 8 U/ML AND OCCASIONAL POSITIVE RESULTS IN THE 100'S U/ML, ALL ANTI-CCP RESULTS WERE BETWEEN 20-60 U/ML. DATA FOR THE RESULTS FOR 39 PATIENT SAMPLES TESTED BETWEEN (B)(6) 2019. NONE OF THE PATIENT SAMPLES WITH QUESTIONABLE HIGH ANTI-CCP RESULTS WERE REPEATED. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E602 MODULE SERIAL NUMBER WAS (B)(4). INVESTIGATIONS ARE ONGOING.