ROCHE 9180 ELECTROLYTE ANALYZER

Additional Manufacturer Narrative

THE CUSTOMER STATED THAT AFTER PERFORMING THE SODIUM CONDITIONER, THE SECOND RE-RUN RESULT WAS WITHIN THE EXPECTED LIMITS. THE CUSTOMER PERFORMED CONDITIONING MORE OFTEN THAN REQUIRED. THE CALIBRATION REPORT FROM 28-APR-2025 SHOWED THAT THE CALIBRATIONS WERE MARKED AS SUCCESSFUL. THE SODIUM ELECTRODE COULD NOT BE PROVIDED FOR AN INVESTIGATION. THE CUSTOMER DID NOT OBSERVE ANY CRYSTALLIZATION. THE INVESTIGATION DETERMINED THAT 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 NA ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE QC WAS WITHIN THE ASSIGNED RANGES ON THE DAY OF THE EVENT. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR 2 PATIENTS' SAMPLES TESTED ON A ROCHE 9180 ELECTROLYTE ANALYZER. RESULTS FOR THE SODIUM (NA) TEST WERE AFFECTED. PATIENT 1: INITIAL RESULT: 114 MMOL/L. REPEAT RESULT: 137 MMOL/L. PATIENT 2: INITIAL RESULT: 116 MMOL/L. REPEAT RESULT: 138 MMOL/L. THE CUSTOMER QUESTIONED THE INITIAL RESULTS AND REPEATED THE SAMPLES. THE REPEAT RESULTS CORRELATED WITH THE PATIENTS' HISTORY AND DIAGNOSIS. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.