DIMENSION® TACROLIMUS FLEX® REAGENT CARTRIDGE

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (08-JULY-2024): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. THE REQUESTED INFORMATION REQUIRED TO INVESTIGATE THIS INCIDENT WAS NOT MADE AVAILABLE TO SIEMENS. MULTIPLE ATTEMPTS WERE MADE TO GATHER MORE INFORMATION TO INVESTIGATE FOR POTENTIAL CAUSE BUT, NO RESPONSE WAS RECEIVED FROM THE CUSTOMER. 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 2517506-2024-00149 WAS FILED ON 16-MAY-2024.

Additional Manufacturer Narrative

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

Description of Event or Problem

A FALSELY ELEVATED TACROLIMUS (TAC) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE FALSELY ELEVATED PATIENT SAMPLE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE CUSTOMER LOOKED BACK INTO THE RECORDS AND FOUND ON (B)(6) 2024 THE PATIENT HAD A LOWER TACROLIMUS (TAC) RESULT. ON (B)(6) 2024 THE SAME SAMPLE WAS TESTED ON THE SAME DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM AND DID NOT PRODUCE A RESULT BUT GENERATED AN ABNORMAL REACTION MESSAGE. THE REDRAWN SAMPLE FROM (B)(6) 2024 WAS SENT OUT TO A REFERENCE LAB USING LIQUID CHROMATOGRAPHY MASS SPECTROMETRY. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED PATIENT SAMPLE RESULT WITH TACROLIMUS (TAC) RESULT.