ELECSYS BRAHMS PCT

Additional Manufacturer Narrative

FOR THE LAST CALIBRATION PERFORMED ON (B)(6) 2019, CALIBRATION SIGNALS WERE LOWER THAN THE EXPECTED MEAN. UPON REVIEW OF THE ALARM TRACE, NO RELEVANT ALARMS WERE OBSERVED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Description of Event or Problem

THE INITIAL REPORTER STATED ON (B)(6) 2019, THEY HAD ISSUES WITH CONTROL RECOVERY FOR ELECSYS BRAHMS PCT ON THEIR COBAS 6000 E 601 MODULE. CONTROLS WERE OUTSIDE OF RANGE. ON (B)(6) 2019, THE REPORTER TRIED USING NEW CONTROL MATERIAL AND THIS RECOVERED WITHIN RANGE. ON (B)(6) 2019, THE REPORTER STATED THE NEW CONTROL MATERIAL WAS USED AGAIN, BUT RECOVERED OUTSIDE OF RANGE. THE REPORTER STATED THEY REPLACED THE REAGENT PACK AND REPEATED TESTING FOR 15 PATIENT SAMPLES. CORRECTED REPORTS WERE ISSUED FOR THESE SAMPLES. THE REPORTER PROVIDED DATA FOR THREE PATIENT SAMPLES WITH DISCREPANT PCT RESULTS. THE INITIAL VALUES WERE REPORTED OUTSIDE OF THE LABORATORY AND THE SAMPLES WERE REPEATED AFTER REPLACING THE REAGENT PACK. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT AND A CORRECTED REPORT WAS ISSUED. THE FIRST SAMPLE INITIALLY RESULTED WITH A PCT VALUE OF 7.13 NG/ML. THE SAMPLE WAS REPEATED, RESULTING AS 14.41 NG/ML. THE SECOND SAMPLE, FROM A (B)(6) FEMALE PATIENT, INITIALLY RESULTED WITH A PCT VALUE OF 2.82 NG/ML. THE SAMPLE WAS REPEATED, RESULTING AS 5.40 NG/ML. THE THIRD SAMPLE, FROM A (B)(6) MALE PATIENT, INITIALLY RESULTED WITH A PCT VALUE OF 0.783 NG/ML. THE SAMPLE WAS REPEATED, RESULTING AS 1.92 NG/ML. THE E 601 ANALYZER SERIAL NUMBER IS (B)(4).