ROCHE 9180 ELECTROLYTE ANALYZER

Additional Manufacturer Narrative

SECTION D, DEVICE IDENTIFICATION, WAS UPDATED. RELEVANT FIELDS OF SECTIONS D AND G WERE UPDATED. THE NA ELECTRODE LOT NUMBER WAS 3124454, INSTALLED ON 01-APR-2025. THE ELECTRODE WAS VALID AT THE TIME OF THE EVENT. THE FIELD SERVICE ENGINEER (FSE) CONFIRMED THE NA ELECTRODE HAD SUFFICIENT INNER FLUID. THERE WAS NO EVIDENCE OF LEAKAGE OR CRYSTALLIZATION. NO CUSTOMER MATERIAL OR IMAGES OF ELECTRODES WERE PROVIDED FOR INVESTIGATION. QC WAS ACCEPTABLE. THE ROOT CAUSE OF THE ISSUE WAS RELATED TO A REFERENCE ELECTRODE MANUFACTURED BY DIAMOND DIAGNOSTICS (DD REF ELECTRODE) USED WITH THE 9180 ELECTROLYTE ANALYZER. THE REFERENCE ELECTRODE USED (DD REF ELECTRODE) IS COVERED BY A ROCHE INITIATED RECALL. CUSTOMERS USING THE DD REF ELECTRODE WERE INSTRUCTED TO IMMEDIATELY STOP USING SODIUM (NA) RESULTS FROM THEIR 9180 ANALYZER. THE AFFECTED REFERENCE ELECTRODE WAS NOT DISTRIBUTED IN THE UNITED STATES. CUSTOMERS IN THE UNITED STATES USE THE ROCHE REFERENCE ELECTRODE AND THE REFERENCE ELECTRODE HOUSING. NO FURTHER ACTION IS NEEDED FOR CUSTOMERS IN THE UNITED STATES.

Additional Manufacturer Narrative

THE ANALYZER SERIAL NUMBER WAS (B)(6).

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED WITH ROCHE 9180 SODIUM ELECTRODE (NA) ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE INITIAL RESULT ON THE 9180 ANALYZER WAS 104 MMOL/L. THE REPEAT ON A COBAS PRO ANALYZER WAS 138.2 MMOL/L.