MalfunctionJGS
SODIUM ELECTRODE
Received Jul 7, 2026 · Event occurred Jun 16, 2026
Report 1823260-2026-02719 · MDR key 25731504
Device
Generic name
Electrode, Ion Specific, Sodium
Manufacturer
Roche DiagnosticsCatalog number
10825468001
Lot number
ASKU
Product problems
- Low Test Results
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE C503 ANALYZER SERIAL NUMBER WAS (B)(6).
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR SODIUM ELECTRODE (NA) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 133.7 MMOL/L. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 137.5 MMOL/L AND 140.1 MMOL/L.