SODIUM ELECTRODE
Received Sep 29, 2025 · Event occurred Sep 9, 2025
Report 1823260-2025-03979 · MDR key 23174723
Device
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE CAUSE OF THE EVENT WAS A FAULTY SODIUM ELECTRODE. THE FSE REPLACED THE ELECTRODE AND PERFORMED PRECISION TESTING IN DUPLICATE, CALIBRATION, AND QC SUCCESSFULLY. THE SERVICE MAINTENANCE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C 501 MODULE. THE INITIAL SODIUM RESULT WAS 184 MMOL/L. THE CUSTOMER QUESTIONED THE HIGH RESULT WHICH PROMPTED THEM TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED AND THE RESULT WAS 135 MMOL/L. THE SAMPLE WAS ALSO REPEATED ON ANOTHER ANALYZER AND THE RESULT WAS 135 MMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.