SODIUM ELECTRODE

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE C 501 ANALYZER IS (B)(6). THE FIELD SERVICE ENGINEER DETERMINED THE SODIUM SENSOR WAS CAUSING AIR IN THE FLOW PATH. THE ISE REAGENTS, SIPPER PROBE, TUBING, AND SODIUM SENSOR WERE REPLACED. THE ISE MEASUREMENT BLOCK WAS CLEANED. THE SYSTEM REAGENTS WERE PRIMED AND THE ISE FLOW PATH WAS PROTEINIZED. ISE CHECKS, CONTROLS, AND PRECISION STUDIES WERE RUN. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH THE SODIUM ELECTRODE ON A COBAS 6000 C (501) MODULE. THE CUSTOMER REPEATED PATIENT SAMPLES SINCE THEY WERE TROUBLESHOOTING ISSUES WITH CALIBRATION.. THE FIRST SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 146 MMOL/L AND IT REPEATED AS 141 MMOL/L. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 138 MMOL/L. THE VALUE OF 138 MMOL/L WAS DEEMED CORRECT. THE SECOND SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 136 MMOL/L AND IT REPEATED AS 131 MMOL/L. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 130 MMOL/L.

Additional Manufacturer Narrative

CALIBRATION DATA WAS ACCEPTABLE. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.