DIMENSION®

Additional Manufacturer Narrative

MDR 2517506-2019-00204 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

DISCORDANT, FALSELY ELEVATED TACROLIMUS (TAC) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). A DISCREPANCY OCCURRED BETWEEN THE RESULTS OF A 1:2 DILUTION AND A 1:3 DILUTION. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TAC RESULTS.

Additional Manufacturer Narrative

ORIGINAL MDR 2517506-2019-00206 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 DATA PROVIDED DID NOT INDICATE AN ISSUE WITH THE INSTRUMENT OR ASSAY PERFORMANCE. THE CUSTOMER PERFORMED TWO DILUTIONS ON THE PATIENT SAMPLE; ONE WAS A 1:2 DILUTION AND THE OTHER WAS A 1:3 DILUTION. THE INSTRUCTIONS FOR USE (IFU) FOR TAC STATES THAT ONLY A DILUTION OF ONE PART PATIENT SAMPLE AND ONE PART LEVEL 1 TAC CALIBRATOR IS APPROPRIATE FOR THIS METHOD. THE DILUTED SAMPLES RESULTS WERE CLOSE TO THE RESULTS OF THE UNDILUTED SAMPLE. THE CUSTOMER WAS INSTRUCTED TO RUN THE PATIENTS SERUM FOR TACROLIMUS, HOWEVER THIS WAS NOT PERFORMED. THE DIMENSION TACROLIMUS INSTRUCTIONS FOR USE (IFU) STATES THAT ONLY A DILUTION OF ONE PART PATIENT SAMPLE AND ONE PART LEVEL 1 TAC CALIBRATOR IS APPROPRIATE FOR THIS ASSAY. THE DILUTED SAMPLES RESULTS WERE SIMILAR TO THE RESULTS OF THE UNDILUTED SAMPLE. THE CUSTOMER WAS INSTRUCTED TO PROCESS THE PATIENT'S SERUM FOR TACROLIMUS, HOWEVER THIS WAS NOT PERFORMED. THE DIMENSION TACROLIMUS INSTRUCTIONS FOR USE 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 2517506-2019-00204 WAS FILED FOR THE SAME EVENT.