DIMENSION TACROLIMUS FLEX REAGENT CARTRIDGE

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING A DISCORDANT ELEVATED TACROLIMUS (TAC) RESULT ON ONE (1) PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS A DISCORDANT ELEVATED TACROLIMUS (TAC) RESULT OBTAINED ON ONE (1) PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM WHEN COMPARED TO THE INITIAL RESULT. THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE CUSTOMER REPROCESSED THE SAME PATIENT SAMPLE ON THE ORIGINAL DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE THIRD TEST OBTAINED A RESULT SIMILAR TO THE INITIAL, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED TACROLIMUS (TAC) RESULT.