DIMENSION®

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (02-APR-2024): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. HSC EVALUATED THE INFORMATION PROVIDED BY THE CUSTOMER AND THE INSTRUMENT DATA LOGS. CALIBRATION AND QUALITY CONTROL (QC) RECOVERED WITHIN CUSTOMER'S ACCEPTABLE RANGES. THE CUSTOMER REPEATED THE SAMPLES ON THE SAME SYSTEM AND OBTAINED THE EXPECTED RESULTS, NO DISCREPANCIES WERE OBSERVED WITH OTHER PATIENT RESULTS. THE CAUSE OF THE EVENT IS UNKNOWN. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTIONS H6 HAVE BEEN UPDATED TO REFLECT THE HSC INVESTIGATION. INITIAL MDR 2517506-2024-00010 WAS FILED ON 08-JAN-2024.

Additional Manufacturer Narrative

A UNITED STATES CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER CARE CENTER (CCC) REGARDING FIVE (5) FALSELY ELEVATED TACROLIMUS (TAC) PATIENT RESULTS OBTAINED ON A DIMENSION® EXL¿ 200 SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.

Description of Event or Problem

FIVE (5) DISCORDANT FALSELY ELEVATED TACROLIMUS (TAC) PATIENT RESULTS WERE OBTAINED ON A DIMENSION® EXL¿ 200 SYSTEM. THE FALSELY ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN AND THE RESULTS WERE QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON THE ORIGINAL INSTRUMENT. LOWER RESULTS OBTAINED WERE CONSIDERED CORRECT. CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.