SODIUM ELECTRODE
Received Jul 10, 2025 · Event occurred Jun 28, 2025
Report 1823260-2025-02101 · MDR key 22467745
Device
Generic name
Electrode, Ion Specific, Sodium
Manufacturer
Roche DiagnosticsCatalog number
10825468001
Lot number
DDK
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS PRO ISE ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE FIELD SERVICE ENGINEER FOUND THE ISSUE WAS DUE TO THE ISE ELECTRODES BEING RECENTLY REPLACED. HE CONDITIONED THE ELECTRODES, COMPLETED ISE CHECKS, CALIBRATION, QC, AND PERFORMED PRECISION. ALL RESULTS WERE ACCEPTABLE. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ISE RESULTS FROM THE COBAS PRO ISE ANALYTICAL UNIT. THE INITIAL SODIUM RESULT WAS 153 MMOL/L. THE REPEAT RESULT FROM ANOTHER COBAS PRO ISE ANALYTICAL UNIT WAS 145 MMOL/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.