DIMENSION

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT A FALSELY DEPRESSED SODIUM (NA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. QUALITY CONTROL (QC) WAS ACCEPTABLE PRIOR TO THE ERRONEOUS RESULTS. THE CUSTOMER REPLACED THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) STANDARD A, STANDARD B AND FLUSH, RAN IMT CALIBRATION SUCCESSFULLY. SIEMENS FURTHER EVALUATED THE EVENT AND CONCLUDED THAT THE AIR GAP IN THE STANDARD A AND STANDARD B TUBING, LIKELY INTRODUCED DURING PRIMING AFTER BOTTLE REPLACEMENT POTENTIALLY CONTRIBUTED TO THE FALSELY DEPRESSED NA RESULT. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT A FALSELY DEPRESSED SODIUM (NA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE REPEAT RESULT RECOVERED HIGHER THAN THE INITIAL RESULT AND WAS CONSIDERED CORRECT. THE REPEAT RESULT WAS REPORTED AS CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED NA RESULT.