ROCHE 9180 ELECTROLYTE ANALYZER
Received Aug 15, 2025 · Event occurred Jul 24, 2025
Report 1823260-2025-02518 · MDR key 22817663
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 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.
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF LOW RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED WITH A ROCHE 9180 SODIUM ELECTRODE (NA) ON A ROCHE 9180 ELECTROLYTE ANALYZER. A DISCREPANT LOW RESULT WAS PROVIDED FOR 1 PATIENT SAMPLE TESTED USING A NEW NA ELECTRODE AND A PREVIOUS NA ELECTRODE. THE RESULT USING THE PREVIOUS NA ELECTRODE WAS 131 MMOL/L. THE RESULT USING THE NEW NA ELECTRODE WAS 116 MMOL/L. THE RESULTS USING THE NEW NA ELECTRODE ARE IN QUESTION.
Additional Manufacturer Narrative
THE NA ELECTRODE LOT NUMBER IN QUESTION WAS 31245147 WITH AN EXPIRATION DATE OF 15-AUG-2025.