inforMED
MalfunctionJGS

NA ELECTRODE

Received Nov 26, 2024 · Event occurred Nov 7, 2024

Report 1823260-2024-03448 · MDR key 20784538

Device

Generic name

Electrode, Ion Specific, Sodium

Manufacturer

Roche Diagnostics

Catalog number

10825468001

Lot number

X0148

Product problems

  • Non Reproducible Results
  • Non Reproducible Results

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER REPLACED THE WASTE AND SIPPER NOZZLES, PINCH TUBE, DILUTION VESSEL, AND ALL ELECTRODES. HE PERFORMED ISE CHECKS AND REPEATABILITY TESTING THAT WAS ACCEPTABLE. AFTERWARD, THE CUSTOMER REPORTED NO FURTHER ISSUES. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

Additional Manufacturer Narrative

THE COBAS PURE C 303 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH SODIUM RESULTS FROM THE COBAS PURE C 303 ANALYTICAL UNIT COMPARED TO A COBAS B221 ANALYZER. THE RESULT FROM THE COBAS B221 WAS 141 MMOL/L. THE RESULT FROM THE COBAS C303 ANALYZER WAS 149 MMOL/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.