SODIUM ELECTRODE

Additional Manufacturer Narrative

NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE ACTIONS WERE PERFORMED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE COBAS 8000 ISE MODULE ANALYZER SERIAL NUMBER IS (B)(6). THE CUSTOMER STATED THERE MAY HAVE BEEN A DROP ON THE END OF A PROBE AND HE HAD NOT SEEN THIS BEFORE. THE FIELD SERVICE ENGINEER DETERMINED THERE WAS POSSIBLE CONTAMINATION OF THE ISE REAGENT FLOW PATH. ISE CHECKS REVEALED UNSTABLE VALUES. THE SYSTEM WAS DECONTAMINATED AND THE REAGENTS WERE PRIMED. THE VACUUM NOZZLE AND SOLENOIDS WERE CHECKED. ISE CHECKS WERE MORE STABLE AFTER THESE ACTIONS. CALIBRATION AND CONTROLS PASSED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY HAVE BEEN HAVING ONGOING ISSUES WITH CALIBRATION FAILURES AND QUALITY CONTROL RECOVERY ON THE COBAS 8000 ISE MODULE. A PHYSICIAN QUESTIONED SODIUM ELECTRODE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES. THE CUSTOMER PROVIDED AN EXAMPLE OF ONE PATIENT SAMPLE WITH DISCREPANT SODIUM RESULTS. THE SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 122 MMOL/L. AFTER THE PHYSICIAN QUESTIONED THE RESULT, THE SAMPLE WAS REPEATED ON AN UNKNOWN ANALYZER, RESULTING IN A VALUE OF 134 MMOL/L. THE REPEAT VALUE WAS DEEMED CORRECT.