ISE SODIUM ELECTRODE
Received Jun 23, 2025 · Event occurred May 29, 2025
Report 1823260-2025-01921 · MDR key 22310072
Device
Generic name
Electrode, Ion Specific, Sodium
Manufacturer
Roche DiagnosticsCatalog number
09237216001
Lot number
DKL54
Product problems
- High Test Results
- Output Problem
- High Test Results
- Output Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- 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 ISE SODIUM ELECTRODE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO ISE ANALYTICAL UNIT. THE INITIAL RESULT WAS 148 MMOL/L. THE REPEATED RESULT WAS 140 MMOL/L. THE SAMPLE WAS REPEATED BECAUSE THE INITIAL RESULT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. THE REPEATED RESULT WAS OBTAINED ON ANOTHER MODULE AND WAS BELIEVED TO BE CORRECT.
Additional Manufacturer Narrative
THE CUSTOMER CANCELLED A SERVICE VISIT. THE CUSTOMER PRIMED THE REAGENTS, PERFORMED AIR PURGES, AND PERFORMED MAINTENANCE. THE SODIUM QC WAS ACCEPTABLE. THE INVESTIGATION DID NOT DETERMINE A SPECIFIC ROOT CAUSE, BUT DID DETERMINE THAT THE ISSUE WAS RESOLVED BY THE CUSTOMER'S ACTIONS.