SODIUM ELECTRODE
Received May 18, 2026 · Event occurred Apr 24, 2026
Report 1823260-2026-01941 · MDR key 25203751
Device
Generic name
Electrode, Ion Specific, Sodium
Manufacturer
Roche DiagnosticsCatalog number
10825468001
Lot number
GDQ
Product problems
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE RESULTS FOR 2 PATIENT SAMPLES ON A COBAS PRO ISE ANALYTICAL UNIT. PATIENT 1: THE INITIAL NA RESULT WAS 151 MMOL/L, AND THE REPEATED RESULT WAS 145 MMOL/L. PATIENT 2: THE INITIAL NA RESULT WAS 149 MMOL/L, AND THE REPEATED RESULT WAS 139 MMOL/L. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT. THE SAMPLES WERE REPEATED BECAUSE THE CUSTOMER QUESTIONED THE HIGH RESULTS.
Additional Manufacturer Narrative
THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.