MalfunctionJGS
SODIUM ELECTRODE
Received Jun 15, 2026 · Event occurred May 14, 2026
Report 1823260-2026-02375 · MDR key 25511357
Device
Generic name
Electrode, Ion Specific, Sodium
Manufacturer
Roche DiagnosticsCatalog number
10825468001
Lot number
31254647
Product problems
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS INTEGRA 400 PLUS W/O ISE. THE INITIAL RESULT WAS 141 MMOL/L. THE REPEATED RESULTS WERE 129.19 MMOL/L AND 125.84 MMOL/L.