SODIUM ELECTRODE

Additional Manufacturer Narrative

THE 25-JUL-2025 CALIBRATION HAD ALARMS. THE QC RESULTS WERE WITHIN THE SPECIFIED RANGES. THERE WAS NO INDICATION OF A PERFORMANCE ISSUE WITH THE REAGENT. THE ALARM TRACE HAD INCUBATION, WATER RESERVOIR, AND REAGENT DISK ALARMS. THE FIELD SERVICE ENGINEER EVALUATED THE INSTRUMENT AND DID NOT FIND ANY ISSUES. HE DECONTAMINATED THE ISE FLOWPATH, CHECKED THE FLUIDICS, AND CONDITIONED THE VACUUM LINE. HE RAN CALIBRATION, QC, AND PRECISION TESTING THAT WERE ACCEPTABLE. THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE, BUT THE ISSUE APPEARED TO BE RESOLVED AFTER THE SERVICE ACTIONS.

Description of Event or Problem

THERE WAS AN ALLEGATION OF ANALYZER ERRORS, QC ISSUES, AND QUESTIONABLE ISE RESULTS FROM THE COBAS 8000 COBAS ISE MODULE (DOUBLE). THE SAMPLES WERE REPEATED ON ANOTHER ANALYZER. ONE EXAMPLE WAS PROVIDED. THE INITIAL SODIUM RESULT WAS 144 MMOL/L, AND THE REPEAT RESULT WAS 137 MMOL/L. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

Additional Manufacturer Narrative

THE COBAS 8000 COBAS ISE MODULE (DOUBLE) SERIAL NUMBER WAS (B)(6), THE INVESTIGATION IS ONGOING.