ROCHE 9180 ELECTROLYTE ANALYZER
Received May 28, 2025 · Event occurred May 8, 2025
Report 1823260-2025-01629 · MDR key 22095181
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 NOT PROVIDED. THE FIELD SERVICE ENGINEER REPLACED THE SODIUM ELECTRODE, THE REFERENCE ELECTRODE, AND THE HOUSING. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM RESULTS FROM THE ELECTROLYTE ANALYZER W/O STARTERKIT 9180. THE INITIAL RESULT WAS 109 MMOL/L. THE SAMPLE WAS REPEATED MULTIPLE TIMES, AND THE RESULT WAS WITHIN 1 MMOL/L OF THE INITIAL RESULT. THE SAMPLE WAS THEN TESTED ON AN ALINITY ANALYZER, AND THE RESULT WAS 139 MMOL/L.
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.