ROCHE 9180 ELECTROLYTE ANALYZER
Received Nov 10, 2025 · Event occurred Oct 18, 2025
Report 1823260-2025-04555 · MDR key 23509020
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 ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE SODIUM ELECTRODE ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 110 MMOL/L. THE SYSTEM WAS RE-CALIBRATED AND THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 139 MMOL/L.
Additional Manufacturer Narrative
THE CUSTOMER WAS USING EITHER SODIUM ELECTRODE LOT 31244547 OR 31244548. THESE HAVE AN INSTALL BEFORE DATE OF (B)(6) 2025. ALL ELECTRODES WERE INSTALLED BY THE CUSTOMER IN (B)(6) 2025, THEREFORE THE ELECTRODE WAS EXPIRED AT THE TIME OF INSTALLATION. THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH USE OF AN EXPIRED ELECTRODE. THE CUSTOMER WAS USING A REFERENCE ELECTRODE MANUFACTURED BY DIAMOND DIAGNOSTICS (DD REF ELECTRODE) 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 CUSTOMER CONSIDERED THE REPEAT RESULT TO BE CORRECT AS IT CORRELATED TO THE PATIENT'S CLINICAL FINDINGS.