DIMENSION®

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¿ WITH LM INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS AUTO REPROCESSED ON THE SAME DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM AND THE REPROCESSED RESULT WAS CONSIDERED ERRONEOUS. THE SAME SAMPLE WAS REPROCESSED IN TRIPLICATE ON THE SAME DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM. THE REPROCESSED RESULTS WERE CONSIDERED CORRECT, AND A RESULT OF 135 MMOL/L WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS.

Additional Manufacturer Narrative

A UNITED STATES CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING TWO (2) ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS ON A PATIENT SAMPLE OBTAINED 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 INSTRUMENT DATA FILES AND THE INFORMATION PROVIDED BY THE CUSTOMER. CALIBRATION AND QUALITY CONTROL (QC) RECOVERY WAS WITHIN THE CUSTOMER¿S EXPECTED RANGES, AND NO ISSUES WERE REPORTED WITH THE OTHER PATIENT SAMPLES, INDICATING THAT THE SODIUM (NA) ASSAY WAS PERFORMING ACCEPTABLY. THERE WERE NO ISSUES IDENTIFIED WITH THE INSTRUMENT. THE CAUSE OF THE EVENT IS UNKNOWN. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.