ROCHE 9180 ELECTROLYTE ANALYZER
Received Jun 23, 2025 · Event occurred May 26, 2025
Report 1823260-2025-01909 · MDR key 22306541
Device
Product problems
- Unable to Obtain Readings
- Incorrect, Inadequate or Imprecise Result or Readings
- Unable to Obtain 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 ROCHE 9180 SODIUM ELECTRODE LOT NUMBER IS 31244847. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE ROCHE 9180 SODIUM ELECTRODE RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE ELECTROLYTE ANALYZER W/O STARTERKIT 9180. PATIENT SAMPLE 1: THE INITIAL RESULT USING AN OLD REFERENCE ELECTRODE WITH A NON-ROCHE REFERENCE ELECTRODE HOUSING WAS 93.000 MMOL/L. THE REPEAT RESULT USING A NEW REFERENCE ELECTRODE WITH A NON-ROCHE REFERENCE ELECTRODE HOUSING WAS 142.000 MMOL/L. PATIENT SAMPLE 2: THE HIGH RESULT WAS 113.000 MMOL/L. THE LOW RESULT WAS 102.000 MMOL/L. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY.
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 THE SODIUM (NA) RESULTS FROM THEIR 9180 ANALYZERS. THE AFFECTED REFERENCE ELECTRODE WAS NOT DISTRIBUTED IN THE UNITED STATES. CUSTOMERS IN THE UNITED STATES USE THE ROCHE REFERENCE ELECTRODE AND THE REFERENCE ELECTRODE HOUSING. NO FURTHER ACTION IS NEEDED FOR CUSTOMERS IN THE UNITED STATES.
Additional Manufacturer Narrative
IN THE INITIAL MDR, H11 ADDITIONAL NARRATIVE UPDATE: THE ROCHE 9180 SODIUM ELECTRODE EXPIRATION DATE IS 30-MAY-2025. THE INVESTIGATION INCLUDED A REVIEW OF THE DATA SET PROVIDED BY THE CUSTOMER: THE SODIUM ELECTRODE CALIBRATION FOR ONE STANDARD IS ABOVE THE RANGE. THE QC RESULTS WERE WITHIN THE SPECIFIED RANGES. THE FIELD SERVICE ENGINEER INSPECTED THE ANALYZER AND REPLACED THE REFERENCE HOUSING AND REFERENCE ELECTRODE. THE INVESTIGATION DETERMINED THAT THE EVENT WAS CONSISTENT WITH THE INTERPLAY BETWEEN SPECIFIC CORE COMPONENTS WITHIN THE SYSTEM (NON-ROCHE REFERENCE ELECTRODE, SODIUM ELECTRODE, AND SYSTEM REAGENTS). THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.
Additional Manufacturer Narrative
ON 17-JUL-2025, THE CUSTOMER REPORTED ADDITIONAL QUESTIONABLE ROCHE 9180 SODIUM ELECTRODE RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE ELECTROLYTE ANALYZER W/O STARTERKIT 9180. ON 26-MAY-2025: PATIENT SAMPLE (B)(6) THE INITIAL RESULT WAS 100 MMOL/L WITH A DATA FLAG. THE FIRST REPEAT RESULT WAS 111 MMOL/L WITH A DATA FLAG. THE SECOND REPEAT RESULT WAS 100 MMOL/L WITH A DATA FLAG. PATIENT SAMPLE (B)(6) THE INITIAL RESULT WAS 102 MMOL/L WITH A DATA FLAG. THE FIRST REPEAT RESULT WAS 113 MMOL/L WITH A DATA FLAG.