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 CUSTOMER PROVIDED 9 PATIENT SAMPLES FOR FURTHER INVESTIGATION. THE INVESTIGATION USED ANTI-CCP REAGENT LOTS 368033 AND 376804. THE CUSTOMER'S RESULTS COULD BE CONFIRMED. AFTER PERFORMING A LOT CHANGE, ONE PATIENT RESULT CHANGED FROM NEGATIVE ( <17 U/ML) TO POSITIVE ( >17 U/ML). FURTHER INVESTIGATION HAS DETERMINED THAT THERE IS A LOT TO LOT DISCREPANCY BETWEEN RESULTS. THE SPECIFIC ROOT CAUSE HAS YET TO BE DETERMINED AND THE INVESTIGATION IS STILL ONGOING. THE EVENT OCCURRED IN: (B)(6).

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE RESULTS FOR MULTIPLE PATIENTS WHEN THEY SWITCHED TO NEW LOTS OF ELECSYS ANTI-CCP IMMUNOASSAY REAGENT. TESTING WAS PERFORMED ON A COBAS 6000 E 601 MODULE. THE CUSTOMER STATED THAT WHEN THEY SWITCHED TO LOTS 368033 AND 376804 THEY WERE OBSERVING MORE FALSE-POSITIVE RESULTS. THE CUSTOMER PROVIDED QUESTIONABLE ANTI-CCP RESULTS FOR 9 PATIENTS FROM WHICH 5 HAD DISCREPANT RESULTS. THE RESULTS IN QUESTION WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE COBAS E601 SERIAL NUMBER WAS (B)(4).