DIMENSION®

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS OBTAINED ON THREE (3) PATIENT SAMPLES ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. HSC REVIEWED THE AVAILABLE INSTRUMENT DATA FILES AND THE INFORMATION PROVIDED BY THE CUSTOMER. CALIBRATION AND QUALITY CONTROL (QC) RECOVERY WERE WITHIN THE CUSTOMER¿S EXPECTED RANGES, INDICATING THAT THE NA ASSAY WAS PERFORMING ACCEPTABLY. HSC INDICATED THAT THE CAUSE OF THE EVENT IS CONSISTENT WITH THE SALT BUILDUPS IN CAP OF SALT BRIDGE SOLUTION WHICH WAS RESOLVED BY CLEANING THE SALT BUILDUPS. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.

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 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON THE SAME DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE HIGHER REPROCESSED RESULTS OBTAINED WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS.