ELECSYS BRAHMS PCT

Additional Manufacturer Narrative

(B)(4). (B)(6).

Description of Event or Problem

THE CUSTOMER RECEIVED QUESTIONABLE HIGH PCT BRAHMS (ROCHE) ELECSYS E2G (PROCALCITONIN) RESULTS DURING CORRELATION TESTING FOR A NEW COBAS 8000 E 801 MODULE. THE SAMPLES WERE INITIALLY TESTED (B)(6) 2018 ON A COBAS 8000 E 801 MODULE AND THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2018, THE SAMPLES WERE REPEATED ON A COBAS E 411 IMMUNOASSAY ANALYZER AND TWO COBAS 8000 E 801 MODULES. THE REPEAT RESULTS FROM THE COBAS E 411 IMMUNOASSAY ANALYZER WERE BELIEVED TO BE CORRECT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT WERE NOT PROVIDED.

Additional Manufacturer Narrative

UNIQUE IDENTIFIER (UDI)#: (B)(4). THE DISCREPANT PROCALCITONIN RESULTS FROM THE COBAS E801 WERE BOTH HIGH AND LOW COMPARED TO THE RESULTS FROM THE COBAS E411. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE. ROCHE HAS INFORMED THE CUSTOMER OF POSSIBLE DISCREPANCIES WITH PROCALCITONIN RESULTS BETWEEN THE COBAS E801 AND OTHER ROCHE ANALYZERS AND ADVISED THE CUSTOMER TO DISCONTINUE TESTING ON THE COBAS E801. A RECALL WAS INITIATED. THIS CUSTOMER WAS INFORMED TO STOP USING THE ELECSYS BRAHMS PCT REAGENT ON THE COBAS E801 ANALYZER ON 09-JAN-2018. HOWEVER, THE CUSTOMER CONTINUED TO USE THE REAGENT ON THE COBAS E801 ANALYZER. THE COBAS E411 ANALYZER WAS INSTALLED IN THE HOSPITAL ON 24-JAN-2018 AND THE SPECIMENS WERE REMEASURED WITH BOTH ANALYZERS.