ROCHE 9180 ELECTROLYTE ANALYZER
Received Jul 14, 2025 · Event occurred Jun 18, 2025
Report 1823260-2025-02132 · MDR key 22494499
Device
Product problems
- Incorrect Measurement
- Low Test Results
- Incorrect Measurement
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CORRECTION: SAMPLE 1: INITIAL RESULT: 142 MMOL/L. REPEAT RESULT: 109 MMOL/L. SAMPLE 2: INITIAL RESULT: 136 MMOL/L. REPEAT RESULT: 107 MMOL/L. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
DURING THE INVESTIGATION, IT WAS DETECTED THAT THE REFERENCE ELECTRODE HOUSING AND THE REFERENCE ELECTRODE WERE MANUFACTURED BY DIAMOND DIAGNOSTICS. THE MAINTENANCE, CLEANING, CONDITIONING, CALIBRATION, AND 3 LEVELS OF QC WERE ALL PERFORMED WITH SUCCESSFUL RESULTS, AND WITH NO ISSUES. THE INITIAL INVESTIGATION FINDINGS SUGGESTED THAT THE PROBLEM WAS CONSISTENT WITH THE INTERPLAY BETWEEN SPECIFIC CORE COMPONENTS WITHIN THE SYSTEM (DIAMOND DIAGNOSTIC REFERENCE ELECTRODE, SODIUM ELECTRODE, SNAPPAK), ALONG WITH POTENTIAL DEFICIENCIES IN THE MAIN INSTRUMENT'S OPERATION.
Additional Manufacturer Narrative
THE NA ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. CALIBRATION AND QC WERE ACCEPTABLE. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
WE RECEIVED AN ALLEGATION OF QUESTIONABLE ION-SELECTIVE ELECTRODE (ISE) RESULTS FOR 2 PATIENTS¿ SAMPLES TESTED ON A ROCHE 9180 ELECTROLYTE ANALYZER. RESULTS FOR THE SODIUM (NA) TEST WERE AFFECTED. SAMPLE 1: NA: INITIAL RESULT: 109 MMOL/L. REPEAT RESULT: 142 MMOL/L. SAMPLE 2: NA: INITIAL RESULT: 107 MMOL/L. REPEAT RESULT: 136 MMOL/L. THE CUSTOMER QUESTIONED THE INITIAL RESULTS AND REPEATED THE SAMPLES. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED THAT 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 RESULTS FROM THEIR 9180 ANALYZER. 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.