ELECSYS ANTI-CCP IMMUNOASSAY

Additional Manufacturer Narrative

CALIBRATION DATA AND QC DATA ARE WITHIN EXPECTATIONS. A GENERAL REAGENT ISSUE MOST LIKELY CAN BE EXCLUDED. THE DETECTION OF ANTI-CCP ANTIBODIES IS PERFORMED WITH A MIXTURE OF VARIOUS CCP'S. AS DIFFERENT METHODS USE DIFFERENT MIXTURES INCLUDING DIFFERENT (AMOUNTS) OF THESE PEPTIDES, IT IS VERY LIKELY THAT SPECIFICITY BETWEEN METHODS DIFFERS. THIS IS NOTED IN THE PRODUCT LABELING. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE CUSTOMER COMPLAINED OF A DISCREPANT ELECSYS ANTI-CCP IMMUNOASSAY RESULT FOR 1 PATIENT SAMPLE ON COBAS 8000 E 602 MODULE SERIAL NUMBER (B)(4). THE PATIENT HAD GONE TO THE RHEUMATOLOGIST FOR PAIN. THE INITIAL ANTI-CCP RESULT WAS 213.3 U/L ON THE E 602 MODULE. THE PHYSICIAN QUESTIONED THE RESULT AND THE SAMPLE WAS SENT TO ANOTHER LABORATORY. THE ANTI-CCP RESULT WAS NEGATIVE WITH THE PHARMACIA IMMUNOCAP METHOD. THE ANTI-CCP RESULT WAS 0 U/L WITH THE EURO DIAGNOSTICA ELISA METHOD. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE RHEUMATOLOGIST STATED THAT PATIENTS' ANTI-CCP RESULTS ARE OFTEN POSITIVE WITH ROCHE TESTS AND NEGATIVE WITH OTHER METHODS.