DIMENSION TACROLIMUS FLEX REAGENT CARTRIDGE

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS ERRONEOUSLY ELEVATED TACROLIMUS (TAC) RESULTS ON TWO (2) PATIENT SAMPLES WERE OBTAINED ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM TWICE. LOWER RESULTS WERE OBTAINED, CONSIDERED CORRECT AND ONE OF THE RESULTS WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED TACROLIMUS (TAC) RESULTS.

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING ERRONEOUSLY ELEVATED TACROLIMUS (TAC) PATIENT SAMPLE RESULTS WERE OBTAINED ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE EVENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (27-MAR-2026): SIEMENS HEALTHCARE DIAGNOSTICS SERVICE OPERATIONS SUPPORT (SOS) CONCLUDED THE INVESTIGATION OF THE EVENT. SOS REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER AND THE DATA FROM THE INSTRUMENT. NO REAGENT OR INSTRUMENT ISSUES WERE IDENTIFIED. QUALITY CONTROL (QC) RECOVERED WITHIN THE CUSTOMER¿S LABORATORY RANGES AT THE TIME OF THE EVENT. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE EVENT IS UNKNOWN. THE PATIENT DATA SUGGESTS SAMPLE-RELATED FACTORS INHERENT TO WHOLE BLOOD TACROLIMUS TESTING, SUCH AS VARIABILITY IN SAMPLE HOMOGENIZATION OR SETTLING PRIOR TO ASPIRATION, WHICH MAY AFFECT ANALYTE DISTRIBUTION. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDING AND INVESTIGATION CONCLUSION CODES WERE UPDATED. INITIAL MDR 2517506-2026-00045 WAS FILED ON 02-MAR-2026.