ANTIBODY TO CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP)

Additional Manufacturer Narrative

THE CUSTOMER DID NOT KNOW WHICH REAGENT LOT WAS USED TO INITIALLY TEST THE SAMPLE.

Description of Event or Problem

THE CUSTOMER FIRST REPORTED THAT SINCE (B)(6) 2013, THEY HAD BEEN HAVING ONGOING ISSUES WITH QUALITY CONTROL RECOVERY ON ANTIBODY TO CYCLIC CITRULLINATED PEPTIDE (ANTI-PPC). THE CUSTOMER STARTED USING NEW REAGENT LOT 17233201 ON (B)(6) 2013 ON AN ELECSYS 2010 DISK ANALYZER. THE CUSTOMER RAN A PATIENT COMPARISON ON THIS NEW LOT CONSISTING OF 5 PATIENT SAMPLES. OF THE FIVE SAMPLES, ONE HAD AN ERRONEOUS RESULT THAT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED AS 300.4 U/ML. THE CUSTOMER WAS ASKED, BUT DID NOT KNOW WHEN THE SAMPLE WAS INITIALLY TESTED. THIS INITIAL RESULT WAS BELIEVED TO BE THE CORRECT VALUE. THE SAMPLE WAS REPEATED ON (B)(6) 2013 AS PART OF THE COMPARISON STUDY AND RESULTED AS 189.5 U/ML. THE 189.5 U/ML VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE ELECSYS 2010 DISK ANALYZER SERIAL NUMBER WAS (B)(4). THE CUSTOMER WAS SENT A DIFFERENT REAGENT LOT AND REPEATED 20 SAMPLES THAT WERE RUN OVER THE PAST MONTH. THE INITIAL RESULTS FOR THESE SAMPLES WERE QUESTIONED BUT WERE NOT FOUND TO BE ERRONEOUS. THE MEDICAL DIRECTOR FOR THE SITE STATED THAT THE DIFFERENCES WERE NOT CLINICALLY SIGNIFICANT, SO NO PATIENT REPORTS WERE AMENDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THE REAGENT WAS DEFECTIVE. THE CUSTOMER WAS PROVIDED A NEW REAGENT LOT (173360). THE FIELD SERVICE REPRESENTATIVE CLEANED THE MEASURING CELL MANUALLY, PERFORMED A HIGH VOLTAGE ADJUSTMENT, DELETED PREVIOUS CALIBRATIONS, AND PERFORMED A BLANK CELL CALIBRATION. THE CUSTOMER RAN CALIBRATION AND QUALITY CONTROLS. REAGENT PACK LOT 17233201 PASSED CALIBRATION, BUT CONTROLS FAILED THE CUSTOMER'S 2SD CRITERIA. REAGENT PACK LOT 173660 PASSED CALIBRATION AND CONTROLS WERE ON THE MEAN.

Additional Manufacturer Narrative

A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED.

Additional Manufacturer Narrative

IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.