ROCHE 9180 ELECTROLYTE ANALYZER

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE ELECTROLYTE ANALYZER W/O STARTERKIT 9180. THE SODIUM RESULTS WERE 140.9 MMOL/L, 120 MMOL/L, AND 120 MMOL/L. THE POTASSIUM RESULTS WERE 4.4 MMOL/L, 3.6 MMOL/L, AND 4.8 MMOL/L. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

Additional Manufacturer Narrative

THE ELECTRODE LOT NUMBER WAS 312 50347 WITH AN EXPIRATION DATE OF 12-SEP-2025. THE ELECTRODES WERE REQUESTED TO BE RETURNED FOR FURTHER INVESTIGATION. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

AFTER REPLACING THE ELECTRODES, THE CUSTOMER PERFORMED CLEANING AND CONDITIONING PROCEDURES. THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THE FINDINGS WERE CONSISTENT WITH AN ISSUE BETWEEN THE SPECIFIC CORE COMPONENTS WITHIN THE SYSTEM AND AN ISSUE WITH THE MAIN INSTRUMENT'S OPERATION.