ROCHE 9180 ELECTROLYTE ANALYZER
Received Jul 28, 2025 · Event occurred Jul 7, 2025
Report 1823260-2025-02300 · MDR key 22628877
Device
Product problems
- Incorrect Measurement
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect Measurement
- 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 SODIUM ELECTRODE LOT NUMBER WAS 31250347, WITH AN INSTALL-BEFORE DATE OF 12-SEP-2025. THE CUSTOMER CHANGED A SYSTEM REAGENT PACK AND NOTICED AN IMPROVEMENT IN CONTROL PERFORMANCE AND SAMPLE REPRODUCIBILITY. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT SODIUM ELECTRODE RESULTS FOR ONE PATIENT SAMPLE TESTED ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 142 MMOL/L AND IT REPEATED AS 170 MMOL/L. THE CUSTOMER DID NOT BELIEVE ANY OF THE VALUES TO BE CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AS THE RESULTS DID NOT MATCH THE PATIENT'S CLINICAL CONDITION.
Additional Manufacturer Narrative
THE CUSTOMER LATER CLARIFIED THAT THE 142 MMOL/L SODIUM VALUE WAS CONSIDERED TO BE THE CORRECT VALUE.
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 CALIBRATION VALUES FOR CALIBRATION STANDARD A FOR NA AND K WERE WITHIN RANGE, AND THE VOLTAGE DIFFERENCE IN THE CALIBRATION STANDARDS FOR NA AND CL WERE WITHIN THE ALLOWED RANGE. HOWEVER, THE K A-B VALUE WAS OUT OF RANGE IN THE 11:32 CALIBRATION, AND THE CL STAND A VALUE WAS OUT OF RANGE IN THE 17:35 CALIBRATION. NO CORRECTION FACTORS WERE APPLIED. THE INVESTIGATION FINDINGS SUGGEST THAT THE PROBLEM LIKELY STEMS FROM THE INTERPLAY BETWEEN SPECIFIC CORE COMPONENTS WITHIN THE SYSTEM (REFERENCE ELECTRODE, NA ELECTRODE, SYSTEM REAGENT PACK), ALONG WITH POTENTIAL DEFICIENCIES IN THE MAIN INSTRUMENT'S OPERATION. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED.