DIMENSION®

Additional Manufacturer Narrative

MDR 2517506-2019-00387 WAS FILED ON 16-OCT-2019. ADDITIONAL INFORMATION (28-OCT-2019): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THEIR INVESTIGATION OF THE DISCORDANT FALSELY ELEVATED TACROLIMUS (TAC) RESULT ON THE DIMENSION EXL 200 INSTRUMENT. HSC REVIEWED THE TESTING DATA AS WELL AS THE ORIGINAL INSTRUMENT DATA. HSC REVIEW OF THE INSTRUMENT FILTER DATA PROVIDED SHOWED THAT THE OPTICS ON THE INSTRUMENT WERE NOT WITHIN ACCEPTABLE RANGES. HSC REQUESTED MAINTENANCE BE PERFORMED. INSTRUMENT MAINTENANCE WAS COMPLETED. ADDITIONALLY, A LIST OF MEDICATIONS THE PATIENT WAS TAKING DURING THE TIME OF TESTING WAS PROVIDED TO HSC. THE PATIENT IN QUESTION WAS TAKING NUMEROUS MEDICATIONS INCLUDING MEDROL, WHICH IS A BRAND NAME FOR THE MEDICATION METHYLPREDNISOLONE. METHYLPREDNISOLONE IS LISTED IN THE DIMENSION TACROLIMUS (TAC) INSTRUCTIONS FOR USE (IFU) AS A MEDICATION THAT CAN INCREASE TAC RESULTS ON THE DIMENSION EXL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION.

Additional Manufacturer Narrative

THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED A DISCORDANT ELEVATED TACROLIMUS (TAC) PATIENT RESULT OBTAINED ON A DIMENSION EXL 200 INSTRUMENT. SIEMENS IS INVESTIGATING THE EVENT.

Description of Event or Problem

A DISCORDANT, ELEVATED TACROLIMUS (TAC) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPROCESSED WITH TWO ALTERNATE METHODOLOGIES AND LOWER RESULTS WERE OBTAINED AND REPORTED. THE LOWER RESULTS WERE REGARDED AS CORRECT BY THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED TAC RESULT.