REFERENCE ELECTRODE
Received Dec 18, 2024 · Event occurred Dec 3, 2024
Report 1823260-2024-03738 · MDR key 20968425
Device
Generic name
Ise Reference Electrode
Manufacturer
Roche DiagnosticsCatalog number
21029398001
Lot number
31235047
Product problems
- Low Test Results
- Non Reproducible Results
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MEDWATCH FIELDS D1-D4, G1, AND G4 WERE UPDATED. THE FIELD SERVICE ENGINEER FOUND AN ISSUE WITH THE REFERENCE ELECTRODE TUBING AND FOUND FLUID UNDER THE ELECTRODES. HE REPLACED THE REFERENCE ELECTRODE, PERFORMED INITIALIZATION, AND PERFORMED MECHANICAL CHECKS. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE WITH THE NA ELECTRODE ON A COBAS INTEGRA 400 PLUS. THE INITIAL RESULT WAS 130.2 MMOL/L. THE REPEAT RESULT WAS 138.8 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE ANALYZER WAS (B)(6) .THE INVESTIGATION IS ONGOING.