DIMENSION®

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER CARE CENTER (CCC) AND REPORTED A FALSELY DEPRESSED TACROLIMUS (TAC) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.

Description of Event or Problem

A DISCORDANT FALSELY DEPRESSED TACROLIMUS (TAC) PATIENT RESULT WAS OBTAINED ON A DIMENSION EXL 200 SYSTEM. THE FALSELY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION EXL 200 SYSTEM. THE HIGHER RESULT OBTAINED WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). IN A CORRECTED REPORT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED TAC RESULT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (21-APR-2024): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. HSC REVIEWED THE AVAILABLE INSTRUMENT DATA FILES AND THE INFORMATION PROVIDED BY THE CUSTOMER. THE CUSTOMER WAS UTILIZING AN EXPIRED CALIBRATOR TO PERFORM THE CALIBRATION. ALL LEVELS OF QUALITY CONTROL (QC) VALUES WERE WITHIN THE EXPECTED REFERENCE RANGE HOWEVER, THE VALUES WERE LOWER WHEN COMPARED TO THOSE VALUES OBTAINED BEFORE THE CALIBRATION WITH THE EXPIRED CALIBRATOR. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER. THE CUSTOMER HAS NOT PROVIDED ADDITIONAL INFORMATION. THE CAUSE OF THE EVENT IS UNKNOWN. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION. INITIAL MDR 2517506-2024-00071 WAS FILED WITH THE FDA ON 16-FEB-2024.