NA ELECTRODE

Additional Manufacturer Narrative

THE INVESTIGATION WAS NOT ABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THE ISSUE APPEARED TO BE RESOLVED AFTER THE SERVICE ACTIONS. THE CALIBRATION DATA WAS ACCEPTABLE AND THE QC RECOVERY WAS WITHIN THE PROVIDED RANGES PRIOR TO THE EVENT. THE ANALYZER ALARM TRACE CONTAINED ABNORMAL SAMPLE ASPIRATION AND SAMPLE SHORT ERRORS. THESE ARE INDICATORS OF POSSIBLE POOR SAMPLE QUALITY.

Additional Manufacturer Narrative

THE ANALYZER SERIAL NUMBER WAS (B)(6). THE FIELD SERVICE ENGINEER WAS UNABLE TO DETERMINE A ROOT CAUSE. HE CHECKED AND ADJUSTED THE SAMPLE PROBE AND ISE PROBE, PERFORMED MECHANISM CHECKS, AND CHECKED AND ADJUSTED THE RINSE WATER LEVELS. HE FOUND THE END SQUEEGEE WAS SPLASHING WATER INTERMITTENTLY AND ADJUSTED IT. HE REMOVED AND CLEANED THE SHIELDS OVER THE REACTION DISK. HE PERFORMED ISE CHECKS AND PRECISION TESTING WHICH PASSED WITHIN SPECIFICATIONS. THE CUSTOMER PERFORMED CALIBRATION AND QC WITH RESULTS WITHIN THE CUSTOMER-DEFINED RANGES. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM RESULTS FROM THE COBAS 6000 C 501 ANALYZER. THE INITIAL RESULT WAS 163 MMOL/L AND THE REPEAT RESULT WAS 139 MMOL/L. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.