TACROLIMUS FLEX REAGENT CARTRIDGE

Additional Manufacturer Narrative

SIEMENS FILED INITIAL MDR 2517506-2020-00012 ON 14-JAN-2020. ADDITIONAL INFORMATION (15-JAN-2020): SIEMENS FURTHER INVESTIGATED THE ISSUE. SIEMENS DETERMINED THAT ELEVATED SAMPLE RESULTS WERE ALL PROCESSED FROM THE SAME FLEX OF TACROLIMUS REAGENT. ONCE THE CUSTOMER MOVED TO A NEW FLEX NO ADDITIONAL DISCORDANT RESULTS WERE OBTAINED. SINGLE FLEX OF TACROLIMUS REAGENT POTENTIALLY CONTRIBUTED TO THE DISCORDANT, FALSELY HIGH TACROLIMUS RESULTS. THERE WERE NO INSTRUMENT ISSUES. THE SINGLE FLEX OF TACROLIMUS REAGENT ATTRIBUTED TO FALSELY HIGH TACROLIMUS RESULTS; HOWEVER, NO PROBLEM WAS DETECTED WITH THE SINGLE FLEX OF TACROLIMUS REAGENT. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. SECTION D, G AND H HAVE BEEN UPDATED WITH THE ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT THEY OBTAINED DISCORDANT, FALSELY HIGH TACROLIMUS RESULTS ON A DIMENSION XPAND PLUS WITH HM INSTRUMENT. QUALITY CONTROLS (QC) WERE WITHIN THE ACCEPTABLE RANGES ON THE DAY OF THE EVENT. THE CCC SPECIALIST ASSISTED THE CUSTOMER AND THE CUSTOMER PERFORMED THE FOLLOWING: REPLACED REAGENT 2 (R2) PROBE, PERFORMED ALIGNMENTS ON R2 PROBE, PERFORMED SYSTEM CHECK, AND RAN QC, WHICH RECOVERED ACCEPTABLY. THE CUSTOMER ALSO REPEATED THE AFFECTED PATIENT SAMPLES AND THEY RECOVERED EXPECTEDLY. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE CSE PERFORMED THE FOLLOWING: INSPECTED THE SYSTEM TEST, PERFORMED ALIGNMENTS AND ADJUSTED R2, VERIFIED ALL ALIGNMENTS, PERFORMED SYSTEM CHECK, WHICH RECOVERED ACCEPTABLY. THEN CSE COMPARED BOTH SETS OF SYSTEM CHECK RESULTS AND DETERMINED THAT THE RESULTS FOR R2 WERE SIMILAR TO THE EXPECTED RESULTS.. THE CUSTOMER RAN QC AND THE QC RECOVERED ACCEPTABLY. THE CAUSE OF THE DISCORDANT, FALSELY HIGH TACROLIMUS RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

Description of Event or Problem

DISCORDANT, FALSELY HIGH TACROLIMUS RESULTS WERE OBTAINED ON 7 PATIENT SAMPLES ON A DIMENSION XPAND PLUS WITH HM INSTRUMENT. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER REPLACED THE REAGENT FLEX AND REPEATED THE SAMPLES ON THE SAME INSTRUMENT. THE REPEAT RESULTS WERE LOWER THAN THE DISCORDANT RESULTS. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THE CUSTOMER INDICATED THEIR REFERENCE RANGE FOR TACROLIMUS TO BE 5-19 NG/ML. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY HIGH TACROLIMUS RESULTS.