ROCHE 9180 ELECTROLYTE ANALYZER

Additional Manufacturer Narrative

THE CALIBRATION FAILED ON (B)(6) 2025. DAILY CLEANING AND CONDITIONING WAS PERFORMED. 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 ROCHE REFERENCE ELECTRODE AND REFERENCE ELECTRODE HOUSING. NO FURTHER ACTION IS NEEDED FOR CUSTOMERS IN THE UNITED STATES.

Additional Manufacturer Narrative

THE NA ELECTRODE LOT NUMBER IS 31244548 WITH AN EXPIRATION DATE OF 04-JUL-2025. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE NA ELECTRODE RESULTS FOR 3 PATIENT SAMPLES ON A ROCHE 9180 ELECTROLYTE ANALYZER. PATIENT 1: THE INITIAL RESULT WAS 107 MMOL/L, AND THE REPEATED RESULT WAS 141 MMOL/L. PATIENT 2: THE INITIAL RESULT WAS 105 MMOL/L, AND THE REPEATED RESULT WAS 139 MMOL/L. PATIENT 3: THE INITIAL RESULT WAS 104 MMOL/L, AND THE REPEATED RESULT WAS 140 MMOL/L. THE REPEATED RESULTS WERE OBTAINED IN ANOTHER LABORATORY USING AN UNKNOWN METHOD. THE SAMPLES WERE REPEATED BECAUSE THE INITIAL RESULTS DID NOT MATCH THE CLINICAL STATUS OF THE PATIENTS.