DIMENSION TACROLIMUS FLEX

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER CARE CENTER (CCC) REGARDING AN ERRONEOUSLY DEPRESSED TACROLIMUS (TAC) PATIENT SAMPLE RESULT OBTAINED ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. SIEMENS HEALTHCARE DIAGNOSTICS SERVICE OPERATIONS SUPPORT (SOS) CONCLUDED THE INVESTIGATION OF THE EVENT. SOS EVALUATED THE INFORMATION PROVIDED BY THE CUSTOMER AND THE AVAILABLE INSTRUMENT DATA. QUALITY CONTROL (QC) RECOVERY WAS WITHIN THE CUSTOMER¿S ACCEPTABLE RANGES. THE INSTRUMENT NOR THE ASSAY CAUSED OR CONTRIBUTED TO THE EVENT. THE CAUSE OF THE EVENT IS CONSISTENT WITH A SAMPLE INTEGRITY ISSUE. THE CUSTOMER STATED THE ISSUE WAS RESOLVED AND NO OTHER DISCORDANT RESULTS WERE REPORTED. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED. NO FURTHER EVALUATION IS REQUIRED.

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY DEPRESSED TACROLIMUS (TAC) RESULT WAS OBTAINED ON ONE (1) PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED FOR TACROLIMUS (TAC) ON THE SAME SYSTEM TWO ADDITIONAL TIMES: BOTH TIMES RECOVERING HIGHER THAN THE INITIAL RESULT. ONE OF THE HIGHER RESULTS WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ERRONEOUSLY DEPRESSED TACROLIMUS (TAC) RESULT.