DIMENSION®

Additional Manufacturer Narrative

MDR 2517506-2019-00206 WAS FILED FOR THE SAME EVENT. 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 NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON A DIFFERENT DATE WITH AN ALTERNATE NON-SIEMENS INSTRUMENT AND LOWER RESULTS WERE OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TAC RESULT.

Additional Manufacturer Narrative

ORIGINAL MDR 2517506-2019-00204 WAS FILED 17-MAY-2019. ADDITIONAL INFORMATION (31-MAY-2019): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THEIR INVESTIGATION OF THE DISCORDANT FALSELY ELEVATED TACROLIMUS (TAC) RESULT. HSC EVALUATED THE INFORMATION PROVIDED. REVIEW OF THE INSTRUMENT FILTER DATA PROVIDED DID NOT SHOW ANY INDICATION OF AN INSTRUMENT ISSUE DURING THE TIME OF TESTING. NO ISSUES WERE IDENTIFIED WITH ASSAY PERFORMANCE OR REAGENT DELIVERY. THE CUSTOMER WAS INSTRUCTED TO PROCESS THE PATIENT'S SERUM FOR TACROLIMUS, HOWEVER THIS WAS NOT PERFORMED. THE INSTRUCTIONS DIMENSION TACROLIMUS INSTRUCTIONS FOR USE (IFU) STATES "PATIENT SAMPLES MAY CONTAIN HETEROPHILIC ANTIBODIES THAT COULD REACT IN IMMUNOASSAYS TO GIVE FALSELY ELEVATED OR DEPRESSED RESULTS." THE CAUSE OF THIS EVENT IS UNKNOWN. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION. SUPPLEMENTAL MDR 2517506-2019-00206 WAS FILED FOR THE SAME EVENT.