ELECSYS BRAHMS PCT

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE ELECSYS BRAHMS PCT (PROCALCITONIN) RESULTS FOR ONE PATIENT SAMPLE TESTED ON TWO COBAS E 801 ANALYTICAL UNIT ANALYZERS. THE PROCALCITONIN RESULTS ARE INCONSISTENT WITH THE PATIENT'S CLINICAL STATUS, OTHER TEST RESULTS, AND THE PATIENT'S BACKGROUND. PRIOR TO UNDERGOING DIALYSIS, A SAMPLE WAS COLLECTED FROM THE PATIENT AND TESTED ON THE CUSTOMER'S E801 ANALYZER, RESULTING IN A PROCALCITONIN VALUE OF > 100 NG/ML. THIS SAMPLE HAD A CRP VALUE OF 3.23 MG/DL AND A WHITE BLOOD CELL COUNT OF 6602/UL, SO THERE WERE NO SIGNS OF INFECTION IN THE PATIENT. THE DOCTOR QUESTIONED THE PROCALCITONIN VALUE. THE SAMPLE WAS DILUTED TIMES 5 AND REPEATED ON THE CUSTOMER'S E801 ANALYZER, RESULTING IN A RAW PROCALCITONIN VALUE OF 16.2 NG/ML. THE FINAL VALUE WHEN ACCOUNTING FOR THE DILUTION FACTOR IS 81.0 NG/ML. THE SAMPLE (B)(6) 2026. THE REPEAT PROCALCITONIN RESULT WAS > 100 NG/ML. THE SAMPLE WAS DILUTED 1:5 AND REPEATED ON THIS ANALYZER, RESULTING IN A VALUE OF 79.5 NG/ML.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S E801 ANALYZER IS (B)(6). THE SERIAL NUMBER OF THE (B)(6) ANALYZER USED FOR INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED. THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.