SODIUM ELECTRODE

Additional Manufacturer Narrative

THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE CUSTOMER NOTED THAT "ABNORMAL ASPIRATION" ALARMS HAD OCCURRED. THE FIELD SERVICE REPRESENTATIVE FOUND AN ISSUE WITH THE ISE (ION-SELECTIVE ELECTRODE) SIPPER NOZZLE. HE REPLACED THE SIPPER NOZZLE AND CLEANED THE VALVE, WHICH RESOLVED THE ISSUE. HE PERFORMED CHECKS AND TESTS WITH ACCEPTABLE RESULTS. AFTER SERVICE, NO ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO ISE ANALYTICAL UNIT. THE INITIAL RESULT WAS 138 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER MODULE, AND THE RESULTS WERE 132 MMOL/L AND 132 MMOL/L. THE SAMPLE WAS REPEATED BECAUSE THE INITIAL HIGH RESULT WAS QUESTIONED. THE REPEATED RESULT WAS BELIEVED TO BE CORRECT.