ROCHE 9180 ELECTROLYTE ANALYZER
Received Nov 4, 2025 · Event occurred Oct 15, 2025
Report 1823260-2025-04479 · MDR key 23464178
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Non Reproducible Results
- Incorrect, Inadequate or Imprecise Result or Readings
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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 SODIUM ELECTRODE LOT NUMBER WAS 31250547, AND THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE SODIUM ELECTRODE RESULT FROM THE ROCHE 9180 ELECTROLYTE ANALYZER FOR TWO PATIENTS. PATIENT 1'S INITIAL RESULT WAS 134 MMOL/L, AND THE REPEAT RESULT WAS 143 MMOL/L. PATIENT 2'S INITIAL RESULT WAS 132 MMOL/L, AND THE REPEAT RESULT WAS 149 MMOL/L. THE CUSTOMER IS UNSURE WHICH RESULTS ARE CORRECT.