DIMENSION®

Additional Manufacturer Narrative

MDRS 2517506-2018-00167, 2517506-2018-00168, 2517506-2018-00169, 2517506-2018-00170, 2517506-2018-00171, AND 2517506-2018-00172 WERE ALSO FILED FOR THE SAME INCIDENT. THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) ABOUT A DISCORDANT, FALSELY ELEVATED TACROLIMUS PATIENT RESULT ON A SINGLE PATIENT OBTAINED ON THE DIMENSION EXL INSTRUMENT. SIEMENS IS INVESTIGATING THE INCIDENT.

Description of Event or Problem

A DISCORDANT, FALSELY ELEVATED TACROLIMUS (TAC) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL INSTRUMENT. THIS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS ANALYZED BY A NON-SIEMENS ALTERNATE METHODOLOGY, WHERE A NEGATIVE RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TAC RESULT.

Additional Manufacturer Narrative

ORIGINAL MDR 2517506-2018-00166 WAS FILED 22-MAR-2018. MDRS 2517506-2018-00167, 2517506-2018-00168, 2517506-2018-00169, 2517506-2018-00170, 2517506-2018-00171, AND 2517506-2018-00172 WERE ALSO FILED FOR THE SAME EVENT. ADDITIONAL INFORMATION: 25-APR-2018: SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) EVALUATED THE INFORMATION PROVIDED AND THE RESULTS OF INTERNAL STUDIES PERFORMED ON PATIENT SAMPLES RETURNED BY THE CUSTOMER. CUSTOMER REPORTED FALSELY ELEVATED RESULTS WITH THE DIMENSION TACROLIMUS (TAC) METHOD FROM SEVERAL SAMPLES OVER SEVERAL DAYS DRAWN FROM ONE PATIENT. THESE SAMPLES WERE COLLECTED A WEEK OR MORE AFTER TACROLIMUS ADMINISTRATION HAD BEEN DISCONTINUED. THE LAST DOSE OF TACROLIMUS THAT THE PATIENT RECEIVED WAS (B)(6) 2018, PRIOR TO THE DATES OF TESTING. SOME OF THESE SAMPLES WERE TESTED FOR TACROLIMUS BY THE GC/MS REFERENCE METHOD AND VALUES OF "NON-DETECTED" WERE OBTAINED WHICH MATCHED THE CLINICAL EXPECTATION. QUALITY CONTROL (QC) SAMPLES MEASURED ON THE INSTRUMENT DURING THE DAYS OF TESTING WERE REPORTED TO BE WITHIN ACCEPTANCE LIMITS. THE CUSTOMER HAS NOT REPORTED ANY OTHER PATIENT SAMPLES WHICH DEMONSTRATE FALSELY ELEVATED TACROLIMUS RESULTS OR RESULTS THAT WERE QUESTIONED BY THE LABORATORY OR PHYSICIAN. THE HSC INVESTIGATION CONCLUSION IS THAT THE ISSUE IS CONSISTENT WITH A PATIENT-SPECIFIC INTERFERENCE WITH THE DIMENSION TACROLIMUS (TAC) METHOD CAUSING FALSELY ELEVATED TACROLIMUS RESULTS. THE SOURCE OF THE INTERFERENCE COULD NOT BE IDENTIFIED. THERE IS NO INDICATION OF A POTENTIAL PRODUCT ISSUE OR MALFUNCTION WITH THE DIMENSION TACROLIMUS (TAC) METHOD. SECTION ADVERSE EVENT PROBLEM HAS BEEN UPDATED TO REFLECT THE HSC CONCLUSION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.