NA ELECTRODE

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM RESULTS FROM THE COBAS PRO ISE ANALYTICAL UNIT. SAMPLE 111761155 INITIAL RESULT WAS 149 MMOL/L AND THE REPEAT RESULT WAS 140 MMOL/L. SAMPLE 111761293 INITIAL RESULT WAS 140 MMOL/L AND THE REPEAT RESULT WAS 134 MMOL/L. SAMPLE 111761354 INITIAL RESULT WAS 138 MMOL/L AND THE REPEAT RESULT WAS 132 MMOL/L.

Additional Manufacturer Narrative

THE COBAS PRO ISE ANALYTICAL UNIT SERIAL NUMBER WAS(B)(6) . THE CUSTOMER PERFORMED QUARTERLY MAINTENANCE AND HAS NOT HAD ANY FURTHER ISSUES. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER FOUND THE FLUIDIC PATHWAYS WERE COMPROMISED. HE REQUESTED THE CUSTOMER TO COMPLETE MONTHLY MAINTENANCE. A PRECISION CHECK WAS PERFORMED WITH PASSING RESULTS. AS THE QC RECOVERY WAS ACCEPTABLE THERE WAS NO INDICATION OF A PERFORMANCE ISSUE OF REAGENT. THE ANALYZER ALARM TRACE CONTAINED SAMPLE PROBE, SAMPLE SHORT, AND SAMPLE PROBE ABNORMAL ASPIRATION ALARMS. THIS IS AN INDICATION OF POSSIBLE POOR SAMPLE QUALITY. THE INVESTIGATION DETERMINED THE SERVICE AND CUSTOMER ACTIONS RESOLVED THE ISSUE.