DIMENSION TACROLIMUS FLEX REAGENT CARTRIDGE

Description of Event or Problem

DISCORDANT TACROLIMUS (TAC) RESULTS WERE OBTAINED ON SAMPLES FROM FOUR ADULT PATIENTS ON A DIMENSION EXL 200 INSTRUMENT. ONE PATIENT HAD AN ELEVATED TAC RESULT AND THE THREE OTHER PATIENTS HAD DEPRESSED TAC RESULTS WHEN PROCESSED ON THE DIMENSION EXL 200 INSTRUMENT. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE REPEAT RESULTS MATCHED THE PATIENTS¿ CLINICAL HISTORY. THE QUALITY CONTROL (QC) WAS WITHIN RANGE PRIOR TO RUNNING THE PATIENT SAMPLES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TACROLIMUS (TAC) RESULTS.

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT DISCORDANT TACROLIMUS (TAC) RESULTS WERE OBTAINED ON A DIMENSION EXL INSTRUMENT. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING.

Additional Manufacturer Narrative

SIEMENS FILED INITIAL MDR 2517506-2023-00262 ON NOVEMBER 30, 2023. ADDITIONAL INFORMATION WAS RECEIVED ON JANUARY 27, 2024: THE REQUESTED INFORMATION REQUIRED TO INVESTIGATE THIS EVENT WAS NOT MADE AVAILABLE TO SIEMENS. SIEMENS MADE SEVERAL ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION TO INVESTIGATE THE EVENT HOWEVER, NO RESPONSE WAS RECEIVED FROM THE CUSTOMER. THE CAUSE OF THE DISCORDANT TACROLIMUS (TAC) RESULTS COULD NOT BE DETERMINED DUE TO THE LACK OF INFORMATION PROVIDED. THE ISSUE HAS BEEN RESOLVED THROUGH STANDARD TROUBLESHOOTING BY THE OPERATOR AND THE CUSTOMER IS OPERATIONAL. THERE IS NO EVIDENCE OF A POTENTIAL PRODUCT ISSUE.