CEA ELECSYS

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE CUSTOMER STATED THAT THEY MEASURED CONTROLS FOR CARCINOEMBRYONIC ANTIGEN (CEA) AND NOTED THAT ONE LEVEL OF CONTROL WAS RECOVERING HIGH ON THE E411 ANALYZER. AFTER THIS, THE CUSTOMER TESTED AN UNSPECIFIED NUMBER OF PATIENT SAMPLES AND RESULTS FROM THESE SAMPLES WERE FOUND TO BE ERRONEOUS. NO SPECIFIC RESULT DATA WAS PROVIDED. THE CUSTOMER STATED THAT ALL SAMPLE RESULTS WERE INITIALLY "ABOUT 10 NG/ML" AND THESE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER QUESTIONED THESE RESULTS, SO THE CUSTOMER EXCHANGED THE CURRENT REAGENT PACK FOR A NEW PACK FROM THE SAME LOT, THEN REPEATED THE SAMPLES. AFTER EXCHANGING THE REAGENT, CONTROLS WERE TESTED AND RECOVERY WAS FOUND TO BE BACK TO PREVIOUS LEVELS. THE SAMPLES WERE REPEATED WITH THE NEW PACK AND RESULTED WITH VALUES UNDER 5 NG/ML. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE SERIAL NUMBER OF THE USED E411 ANALYZER WAS ASKED FOR, BUT NOT PROVIDED.

Additional Manufacturer Narrative

THE CUSTOMER PROVIDED DATA FOR THREE PATIENT SAMPLES THAT WERE AFFECTED. THE FIRST PATIENT SAMPLE INITIALLY RESULTED AS 8.34 NG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. AFTER THE REAGENT PACK WAS REPLACED, THE SAMPLE WAS REPEATED, RESULTING AS 1.47 NG/ML. THE SECOND PATIENT SAMPLE INITIALLY RESULTED AS 10.53 NG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. AFTER THE REAGENT PACK WAS REPLACED, THE SAMPLE WAS REPEATED, RESULTING AS 3.59 NG/ML. THE THIRD PATIENT SAMPLE INITIALLY RESULTED AS 11.48 NG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. AFTER THE REAGENT PACK WAS REPLACED, THE SAMPLE WAS REPEATED, RESULTING AS 3.98 NG/ML. THE QUESTIONABLE REAGENT PACK WAS INVESTIGATED WHERE IT WAS DETERMINED THAT THERE WAS HIGH CALIBRATION SIGNAL RECOVERY CAUSED BY A REAGENT WITHIN THE PACK. CONTROLS WERE MEASURED ON THE QUESTIONED PACK AND WERE CALCULATED TO BE OUT OF RANGE WHEN USING THE CALIBRATION RESULT OF RETENTION REAGENT.

Additional Manufacturer Narrative

A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. INVESTIGATIONS CONCLUDE THAT THERE WAS HIGHER SIGNAL RECOVERY WITH THE R2 REAGENT WITHIN THE REAGENT PACK. THE REASON FOR THE HIGHER RECOVERY IS UNKNOWN. THE ISSUE OCCURRED ONLY WITH A SINGLE REAGENT KIT. NO OTHER COMPLAINTS OF THIS NATURE HAVE BEEN RECEIVED.