DIMENSION

Description of Event or Problem

THE CUSTOMER REPORTED THAT AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPROCESSED ON THE ORIGINAL SYSTEM. THE REPROCESSED RESULT WAS HIGHER THAN THE ERRONEOUS RESULT. THE REPROCESSED RESULT WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT.

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER CONTACTED A SIEMENS REMOTE SERVICES CENTER (RSC) AND REPORTED THAT AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. CALIBRATION WAS ACCEPTABLE, AND QUALITY CONTROL (QC) WAS WITHIN RANGE ON THE DAY OF THE EVENT. SIEMENS IS EVALUATING THE EVENT.