DIMENSION

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) REGARDING AN ERRONEOUSLY ELEVATED TACROLIMUS (TAC) RESULT ON A PATIENT SAMPLE OBTAINED ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. QUALITY CONTROL (QC) AND CALIBRATION RECOVERED WITHIN THE ACCEPTABLE RANGES ON THE DATE OF THE EVENT. SIEMENS EVALUATED THE PATIENT¿S REPRODUCIBILITY DATA, ASPIRATION PRESSURE PROFILES, CLOT-CHECK INFORMATION, AND PHOTOMETRIC REACTION DATA, WHICH DEMONSTRATED PRESSURE VARIATION DURING THE INITIAL ASPIRATION EVENT, WHILE REPEAT ANALYSES SHOWED STABLE ASPIRATION PATTERNS AND CONSISTENT REACTION PERFORMANCE. SIEMENS DID NOT IDENTIFY ANY EVIDENCE OF SYSTEM MALFUNCTION, REAGENT PERFORMANCE ISSUE, CALIBRATION INSTABILITY, OR ASSAY-RELATED FAILURE. SIEMENS FURTHER EVALUATED THE EVENT AND DETERMINED THAT THE SAMPLE-RELATED ASPIRATION DISTURBANCE (KIND OF FIBRIN/MICRO-CLOT) CONTRIBUTED TO THE ERRONEOUSLY ELEVATED TAC RESULT. A PRODUCT PROBLEM HAS NOT BEEN IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE WAS RESOLVED BY ROUTINE TROUBLESHOOTING. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED TACROLIMUS (TAC) RESULT ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED TWICE ON THE ORIGINAL DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE REPEAT RESULTS RECOVERED LOWER THAN THE INITIAL RESULT AND MATCHED THE PATIENT¿S CLINICAL HISTORY. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED TACROLIMUS (TAC) RESULT.