ELECSYS ANTI-CCP IMMUNOASSAY

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS ANTI-CCP ASSAY ON A COBAS 6000 E 601 MODULE. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO UNITS OF MEASURE WERE PROVIDED FOR THE ANTI-CCP ASSAY. THE SAMPLE WAS TESTED THREE TIMES, RESULTING WITH ANTI-CCP VALUES OF 19.4, 51.7, AND 51.6. THE PROBE WAS WASHED AND THE SAMPLE WAS REPEATED TWO MORE TIMES, RESULTING WITH VALUES OF 24.7 AND 44.7. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE ANTI-CCP REAGENT LOT NUMBER WAS 368033. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. PRECISION STUDIES WERE PERFORMED. THE FIELD SERVICE ENGINEER CHANGED THE MEASURING CELLS OF THE ANALYZER.

Additional Manufacturer Narrative

THE UNIT OF MEASURE USED FOR THE ANTI-CCP ASSAY IS U/ML. THE CUSTOMER PROVIDED DATA FOR 7 ADDITIONAL SAMPLES WITH QUESTIONABLE ANTI-CCP RESULTS. OF THESE, THREE HAD DISCREPANT RESULTS. INCORRECT RESULTS FOR THESE THREE SAMPLES WERE REPORTED OUTSIDE OF THE LABORATORY. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THESE PATIENTS. THE SERUM TUBE OF THE FIRST ADDITIONAL SAMPLE INITIALLY RESULTED WITH AN ANTI-CCP VALUE OF < 7.00 U/ML ON (B)(6) 2019. THE PLASMA TUBE OF THE SAMPLE WAS REPEATED, RESULTING WITH A VALUE OF 34.04 U/ML. THE SERUM TUBE OF THE SECOND ADDITIONAL SAMPLE INITIALLY RESULTED WITH AN ANTI-CCP VALUE OF < 7.00 U/ML ON (B)(6) 2019 THE PLASMA TUBE OF THE SAMPLE WAS REPEATED, RESULTING WITH A VALUE OF 27.10 U/ML. THE SERUM TUBE OF THE THIRD ADDITIONAL SAMPLE INITIALLY RESULTED WITH AN ANTI-CCP VALUE OF < 7.00 U/ML ON (B)(6) 2019. THE PLASMA TUBE OF THE SAMPLE WAS REPEATED, RESULTING WITH A VALUE OF 21.35 U/ML. THE CUSTOMER RETURNED SAMPLES FOR INVESTIGATION. THE CUSTOMER¿S RESULTS COULD NOT BE CONFIRMED AS BOTH SAMPLES WERE BELOW THE LIMIT OF BLANK FOR THE ASSAY IN ALL CASES. A DISCREPANCY BETWEEN SERUM AND PLASMA SAMPLES COULD NOT BE CONFIRMED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE EXPIRATION DATE OF THE ANTI-CCP REAGENT LOT 368033 WAS 30-JUNE-2019. MEDWATCH FIELD D4 WAS UPDATED.

Additional Manufacturer Narrative

THE FOLLOWING MEDWATCH FIELDS HAVE BEEN UPDATED: BRAND NAME, COMMON DEVICE NAME, PROCODE, MFR SITE.