ROCHE 9180 ELECTROLYTE ANALYZER
Received Apr 23, 2026 · Event occurred Apr 1, 2026
Report 1823260-2026-01569 · MDR key 24969781
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF DISCREPANT LOW RESULTS FOR 2 PATIENT SAMPLES TESTED FOR SODIUM (NA) ON A ROCHE 9180 ELECTROLYTE ANALYZER. PATIENT 1 INITIAL RESULT WAS 109 MMOL/L. THE REPEAT RESULT WAS 136 MMOL/L. PATIENT 2 INITIAL RESULT WAS 112 MMOL/L. THE REPEAT RESULT WAS 141 MMOL/L. RECALIBRATION WAS PERFORMED BETWEEN THE INITIAL AND REPEAT RESULTS.
Additional Manufacturer Narrative
THE NA ELECTRODE LOT NUMBER WAS 31263947. THE EXPIRATION DATE WAS NOT PROVIDED. QC WAS ACCEPTABLE. 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.