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 DiagnosticsCatalog 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.