DIMENSION®

Additional Manufacturer Narrative

MDRS 2517506-2019-00021, 2517506-2019-00022, 2517506-2019-00023 WERE ALSO FILED ON (B)(6) 2019 FOR THE SAME EVENT. ADDITIONAL INFORMATION ((B)(6) 2019): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THEIR INVESTIGATION OF THE DISCORDANT FALSELY ELEVATED TACROLIMUS (TAC) RESULT. HSC EVALUATED THE INFORMATION PROVIDED AND THE INSTRUMENT DATA FILES. NO PRODUCT NONCONFORMANCE WAS IDENTIFIED. THE CAUSE OF THE EVENT IS UNKNOWN. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION.

Additional Manufacturer Narrative

MDRS 2517506-2019-00021 AND 2517506-2019-00022 WERE ALSO FILED FOR THE SAME EVENT. THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED A DISCORDANT, FALSELY ELEVATED TACROLIMUS (TAC) PATIENT RESULT OBTAINED ON THE DIMENSION RXL SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.

Description of Event or Problem

A DISCORDANT ELEVATED TACROLIMUS (TAC) RESULT WAS OBTAINED (B)(6) 2018 ON A PATIENT SAMPLE ON A DIMENSION RXL INSTRUMENT. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE DIMENSION RXL INSTRUMENT AND A SIMILARLY ELEVATED TAC RESULT WAS OBTAINED. A SAMPLE FROM THE SAME PATIENT HAD BEEN PROCESSED WITH AN ALTERNATE METHODOLOGY AND A LOWER RESULT WAS OBTAINED WHICH WAS CONSIDERED CORRECT BY THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED TAC RESULT.