SODIUM ELECTRODE
Received Jul 17, 2026 · Event occurred Jun 19, 2026
Report 1823260-2026-02903 · MDR key 25855392
Device
Generic name
Electrode, Ion Specific, Sodium
Manufacturer
Roche DiagnosticsCatalog number
10825468001
Lot number
GWC97
Product problems
- High Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS ISE NEO 1800.THE INITIAL RESULT WAS 147 MMOL/L.THE SAMPLE WAS REPEATED ON ANOTHER MODULE (MODULE 2), AND THE RESULT WAS 135 MMOL/L.THE SAMPLE WAS REPEATED ON ANOTHER MODULE (MODULE 3), AND THE RESULT WAS 137 MMOL/L.THE SAMPLE WAS REPEATED BECAUSE THE INITIAL RESULT DIDN'T MATCH THE PATIENT'S CLINICAL HISTORY.
Additional Manufacturer Narrative
E1 INITIAL REPORTER ESTABLISHMENT NAME: UNIVERSITY HOSPITAL WURZBURG, PUBLIC CORPORATION, CENTRAL LABORATORY ZIM A4.-2.965THE ANALYZER'S SERIAL NUMBER IS (b)(6).THE INVESTIGATION IS ONGOING.