DIMENSION®

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING ERRONEOUSLY DEPRESSED TACROLIMUS (TAC) RESULTS OBTAINED ON SIX (6) PATIENT SAMPLES ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. SIEMENS IS EVALUATING THE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY DEPRESSED TACROLIMUS (TAC) RESULTS ON SIX (6) PATIENT SAMPLES ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE QUESTIONED. THE SAME SAMPLES WERE SENT TO AN ALTERNATE FACILITY AND REPROCESSED ON AN ALTERNATE NON-SIEMENS INSTRUMENT. THE REPROCESSED RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THE CUSTOMER DID NOT PROVIDE THE PATIENT RESULTS OBTAINED FROM AN ALTERNATE NON-SIEMENS INSTRUMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED TACROLIMUS (TAC) RESULTS.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 2517506-2025-00051 ON 26-MAR-2025. ADDITIONAL INFORMATION (11-NOV-2025): SIEMENS HEALTHCARE DIAGNOSTICS CONCLUDED THE INVESTIGATION OF THE EVENT. SIEMENS EVALUATED THE INSTRUMENT DATA, AND THE INFORMATION PROVIDED BY THE CUSTOMER. CALIBRATION WAS ACCEPTABLE, AND QUALITY CONTROL (QC) WAS WITHIN THE CUSTOMER'S ACCEPTABLE RANGES. SIEMENS REVIEWED THE INSTRUMENT DATA AND FOUND THAT THE SYSTEM CHECK WAS ACCEPTABLE, AND THE TACROLIMUS (TAC) REAGENT LOT DEMONSTRATED REDUCED REACTIVITY. SIEMENS COULD NOT PERFORM ADDITIONAL STUDIES AS THE TAC REAGENT LOT WAS NEAR EXPIRY. THE CUSTOMER PERFORMED A COMPARISON STUDY, AND THE RESULTS WERE NOT CONSIDERED ACCEPTABLE. SIEMENS REVIEWED THE TAC REAGENT RELEASE RECORDS FOR THE AFFECTED LOT AND FOUND NO ANOMALIES. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULTS CANNOT BE DETERMINED AND IS INCONCLUSIVE DUE TO DATA LIMITATIONS. THE CUSTOMER IS OPERATIONAL. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. NOTE: IN SECTION H6, THE CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED TO REFLECT THE ADDITIONAL INFORMATION.