ROCHE 9180 ELECTROLYTE ANALYZER
Received Oct 7, 2025 · Event occurred Sep 16, 2025
Report 1823260-2025-04093 · MDR key 23235628
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE NA ELECTRODE LOT NUMBER WAS 407385. THE EXPIRATION DATE WAS NOT PROVIDED.
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR SODIUM (NA) ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE RESULT FROM THE 9180 ELECTROLYTE ANALYZER WAS 119 MMOL/L. THE RESULT FROM A COBAS B221 BLOOD GAS ANALYZER WAS 135 MMOL/L.
Additional Manufacturer Narrative
THE CUSTOMER USES REFERENCE ELECTRODES MANUFACTURED BY DIAMOND DIAGNOSTICS. 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 THE 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.