DIMENSION®

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (03-MAR-2025): SIEMENS HEALTHCARE DIAGNOSTICS CONCLUDED THE INVESTIGATION OF THE EVENT. SIEMENS REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER AND INSTRUMENT DATA FILES. QUALITY CONTROL (QC) AND CALIBRATION RECOVERED WITHIN THE CUSTOMER¿S EXPECTED RANGES, INDICATING THAT THE SODIUM (NA) ASSAY WAS PERFORMING ACCEPTABLY AND ALSO NO ISSUES WITH SAMPLE INTEGRITY. NO INSTRUMENT ERRORS WERE OBSERVED AT THE TIME OF THE EVENT. THE CAUSE OF THE EVENT IS UNKNOWN. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE SIEMENS INVESTIGATION. INITIAL MDR 2517506-2025-00029 WAS FILED ON 25-FEB-2025.

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING TWO (2) ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. SIEMENS IS EVALUATING THE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED TWO (2) ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE INITIAL RESULT OBTAINED WAS CRITICALLY LOW AND THE SAME SAMPLE WAS AUTO REPROCESSED ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE AUTO REPROCESSED RESULT RECOVERED LOW AND WAS CONSIDERED ERRONEOUS. THE AUTO REPROCESSED RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM ON THE NEXT DAY AND A HIGHER RESULT WAS OBTAINED. THE HIGHER REPROCESSED RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. ON THE EVENT DATE, A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PROCESSED ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM AND A HIGHER RESULT WAS OBTAINED. THE SAME REDRAWN SAMPLE WAS REPROCESSED ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM ON THE NEXT DAY AND A HIGHER RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS.