ATELLICA CH

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. CALIBRATION WAS ACCEPTABLE, AND QUALITY CONTROL (QC) RECOVERED WITHIN RANGE ON THE EVENT DATE. THE CUSTOMER RECALIBRATED THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT), AND REPEATED QC, WHICH RECOVERED WITHIN RANGE. SIEMENS FURTHER EVALUATED THE EVENT AND CONCLUDED THAT THE CAUSE OF THE ERRONEOUS NA RESULT IS CONSISTENT WITH A SAMPLE INTEGRITY BEHAVIOR, MOST LIKELY, FIBRIN IN THE SAMPLE WAS ASPIRATED ON THE INITIAL ASPIRATION CAUSING A DECREASED SAMPLE VOLUME TO BE ASPIRATED THUS CAUSING THE LOWER NA RECOVERY. THE INITIAL ASPIRATION CLEARED THE FIBRIN FROM THE SAMPLE AND REPEAT ASPIRATIONS WERE NOT AFFECTED. THE REPORTED ISSUE WAS RESOLVED WITH STANDARD TROUBLESHOOTING ACTIONS. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBSERVED AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. A NEW SAMPLE WAS REDRAWN FROM THE SAME PATIENT AND PROCESSED ON THE ORIGINAL ATELLICA CH 930 ANALYZER. THE REDRAWN RESULT OBTAINED WAS CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.