DIMENSION®

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (05-AUG-2024): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. HSC REVIEWED THE INSTRUMENT DATA FILES AND THE INFORMATION PROVIDED BY THE CUSTOMER. CALIBRATION AND QUALITY CONTROL (QC) RECOVERY WAS WITHIN THE CUSTOMER¿S EXPECTED RANGES, INDICATING THAT THE SODIUM (NA) ASSAY WAS PERFORMING ACCEPTABLY. HSC CONCLUDED THAT THE CAUSE OF THE EVENT WAS CONSISTENT WITH DILUTION CHECK CORRECTION FACTOR NOT IN NORMAL RANGE. THE ISSUE WAS RESOLVED BY RESETTING THE CORRECTION FACTOR AND RUNNING A FRESH NEW BOTTLE OF DILUTION CHECK SOLUTION. 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 2517506-2024-00201 WAS FILED ON 26-JUL-2024.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS ON THREE (3) PATIENT SAMPLES OBTAINED ON A DIMENSION EXL WITH LM SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS ON THREE (3) PATIENT SAMPLES ON A DIMENSION EXL WITH LM SYSTEM. THE ERRONEOUSLY DEPRESSED PATIENT RESULTS WERE NOT REPORTED TO PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE SAME DIMENSION EXL WITH LM SYSTEM. THE REPROCESSED RESULTS RECOVERED HIGHER AND WERE REPORTED AS CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS.