DIMENSION®

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (03-JUNE-2023): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. HSC EVALUATED THE INFORMATION PROVIDED BY THE CUSTOMER AND THE INSTRUMENT DATA LOGS. HSC OBSERVED THAT THE SERIAL DILUTION OF THE SAMPLE SHOWS A NON-LINEAR RECOVERY CONSISTENT WITH A NON-SPECIFIC BINDING (NSB) OR HETEROPHILE ANTIBODY WHICH IS LISTED AS A POSSIBLE INTERFERENCE IN THE DIMENSION TACROLIMUS (TAC) INSTRUCTIONS FOR USE (IFU). WHEN A PATIENT-SPECIFIC INTERFERENT IS PRESENT, TESTING SHOULD NOT BE PERFORMED USING THIS TESTING METHODOLOGY UNTIL THE INTERFERENCE IS NO LONGER PRESENT. THE CAUSE OF THE EVENT WAS DETERMINED TO BE THE POTENTIAL PRESENCE OF HETEROPHILE ANTIBODIES OR NON-SPECIFIC BINDING (NSB) INTERFERENCE. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED. THE TACROLIMUS (TAC) IFU STATES: "PATIENT SAMPLES MAY CONTAIN HETEROPHILIC ANTIBODIES THAT COULD REACT IN IMMUNOASSAYS TO GIVE FALSELY ELEVATED OR DEPRESSED RESULTS. ANTIBODIES TO ¿-GALACTOSIDASE CAN BE ENCOUNTERED IN SAMPLES AS A CONSEQUENCE OF BACTERIAL INFECTION AND MAY PRODUCE FALSELY ELEVATED RESULTS WHICH MAY NOT BE CONSISTENT WITH CLINICAL EVALUATION. THE ASSAY HAS BEEN DESIGNED TO MINIMIZE INTERFERENCE FROM ANTIBODIES TO ¿-GALACTOSIDASE. IN VERY RARE INSTANCES, IMMUNOASSAYS MAY PRODUCE FALSELY ELEVATED OR DECREASED RESULTS DUE TO OTHER PATIENT-SPECIFIC INTERFERENTS. A NUMBER OF THESE INTERFERENTS ARE PRESENT IN THE PLASMA OF AFFECTED PATIENT SAMPLES AND WILL BE DETECTED BY THE AUTOMATIC RERUN PROCEDURE. COMPLETE ELIMINATION OF SUCH INTERFERENCE FROM ALL PATIENT SPECIMENS CANNOT BE GUARANTEED. A TEST RESULT THAT IS INCONSISTENT WITH THE CLINICAL PICTURE AND PATIENT HISTORY SHOULD BE INTERPRETED WITH CAUTION. CONFIRMATION OF UNEXPECTED OR ATYPICAL RESULTS BY AN ALTERNATIVE METHODOLOGY IS RECOMMENDED PRIOR TO ANY ADJUSTMENTS IN TACROLIMUS DOSAGE." THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION. INITIAL MDR 2432235-2023-00113 WAS FILED ON 19-MAY-2023.

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING ONE (1) FALSELY ELEVATED TACROLIMUS (TAC) PATIENT SAMPLE RESULT OBTAINED ON A DIMENSION EXL 200 INSTRUMENT. 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 INSTRUMENT. THE FALSELY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON TWO ALTERNATE NON-SIEMENS INSTRUMENTS. THE REPEAT RESULTS MATCHED WITH THE CLINICAL PICTURE AND WERE CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED TAC RESULT.