DIMENSION TACROLIMUS FLEX REAGENT CARTRIDGE

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED TACROLIMUS (TAC) RESULT WAS OBTAINED ON 1 PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE CORRECT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT A FALSELY ELEVATED TACROLIMUS (TAC) RESULT WAS OBTAINED ON 1 PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. QUALITY CONTROLS (QCS) RECOVERED WITHIN RANGES ON THE DAY OF THE EVENT. SIEMENS IS EVALUATING THE EVENT.