DIMENSION TACROLIMUS FLEX

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (12-MAY-2026): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SERVICE OPERATIONS SUPPORT (SOS) TEAM CONCLUDED THE INVESTIGATION OF THE EVENT. SOS REVIEWED THE INSTRUMENT DATA FILES AND THE INFORMATION PROVIDED BY THE CUSTOMER. QUALITY CONTROL (QC) RECOVERY WAS WITHIN THE CUSTOMER¿S EXPECTED RANGES. THE ISSUE WAS RESOLVED WITH STANDARD TROUBLESHOOTING BY REPEATING THE SAMPLE WITH AND WITHOUT DILUTION. NO REAGENT NOR INSTRUMENT ISSUES WERE IDENTIFIED. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED. THE CAUSE OF THE EVENT WAS CONSISTENT WITH A SAMPLE SPECIFIC ISSUE. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY ELEVATED TACROLIMUS (TAC) RESULT WAS OBTAINED ON ONE (1) PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM THREE ADDITIONAL TIMES: ONCE USING A 1:2 DILUTION, USING NO DILUTION, AND USING ANOTHER 1:2 DILUTION. LOWER RESULTS WERE OBTAINED. THE RESULT OBTAINED USING THE SECOND 1:2 DILUTION WAS 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.