DIMENSION TACROLIMUS FLEX REAGENT CARTRIDGE

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING A FALSELY ELEVATED TACROLIMUS (TAC) PATIENT RESULT OBTAINED ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED THAT AN ERRONEOUSLY ELEVATED TACROLIMUS (TAC) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPROCESSED TWICE ON THE ORIGINAL INSTRUMENT. THE FIRST REPEAT RESULT RECOVERED HIGHER THAN THE INITIAL RESULT AND WAS CONSIDERED ERRONEOUS. THE SECOND REPEAT RESULT RECOVERED SIMILAR TO THE INITIAL RESULT. THE INITIAL AND THE SECOND REPEAT RESULTS WERE CONSIDERED CORRECT AND THE RESULT OF 10.4 NG/ML WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED TAC RESULT.