ELECTRODE, SODIUM
Received Oct 28, 2025 · Event occurred Oct 5, 2025
Report 1823260-2025-04380 · MDR key 23405419
Device
Generic name
Electrode, Ion Specific, Sodium
Manufacturer
Roche DiagnosticsCatalog number
21029371001
Lot number
ASKU
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Failure to Calibrate
- Calibration Problem
- Incorrect, Inadequate or Imprecise Result or Readings
- Failure to Calibrate
- Calibration Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER STATED THAT THEIR QC WAS NOT WITHIN SPECIFICATION. THE SERVICE MAINTENANCE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECTRODE, SODIUM RESULTS FOR 1 PATIENT SAMPLE ON A COBAS INTEGRA 400 PLUS MODULE. THE INITIAL RESULT WAS 123 MMOL/L. THE CUSTOMER QUESTIONED THE LOW RESULT WHICH PROMPTED THEM TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED ON A COBAS 6000 ANALYZER AND THE RESULT WAS 137 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE CUSTOMER STATED THEY HAD ION-SELECTIVE ELECTRODE (ISE) CALIBRATION FAILURES. THE FIELD SERVICE ENGINEER (FSE) PERFORMED ELECTRODE SERVICE, REPLACED ISE TUBING, AND PERFORMED ISE PRECISION TESTING, CALIBRATION, AND QC SUCCESSFULLY. THE INVESTIGATION IS ONGOING.