ELECTRODE, SODIUM
Received Mar 12, 2025 · Event occurred Feb 10, 2025
Report 1823260-2025-00708 · MDR key 21582990
Device
Generic name
Electrode, Ion Specific, Sodium
Manufacturer
Roche DiagnosticsCatalog number
21029371001
Lot number
ASKU
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 REPRESENTATIVE REMOTELY ASSISTED THE CUSTOMER IN REPLACING THE NA ELECTRODE, EXTRA ACTIVATION, AND AIR/WATER CALIBRATION, WHICH RESOLVED THE CALIBRATION ISSUES. THE CUSTOMER DID NOT REPORT ANY OTHER ISSUES. THE INVESTIGATION DETERMINED THAT THE CUSTOMER'S ACTION (NA ELECTRODE REPLACEMENT) RESOLVED THE ISSUE.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE CUSTOMER'S COBAS INTEGRA 400 PLUS IS (B)(6). THE CALIBRATION RESULTS HAD DATA FLAGS. THE QC RESULTS HAD DATA FLAGS SURROUNDING THE DATE OF EVENT. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE NA ELECTRODE ASSAY RESULTS FROM MULTIPLE PATIENT SAMPLES TESTED ON THE COBAS INTEGRA 400 PLUS. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS FROM THE ANALYZER: SAMPLE 1 THE INITIAL NA RESULT WAS 132 MMOL/L. THE REPEAT RESULT WAS 139 MMOL/L. SAMPLE 2 THE INITIAL NA RESULT WAS 132 MMOL/L. THE REPEAT RESULT WAS 138 MMOL/L. SAMPLE 3 THE INITIAL NA RESULT WAS 134 MMOL/L. THE REPEAT RESULT WAS 140 MMOL/L. THE INITIAL RESULTS WERE BELOW THE REFERENCE RANGE, PROMPTING THE PATIENT SAMPLE RERUNS. THE REPEAT RESULTS WERE DEEMED CORRECT. THE REPORTER STATED THEY ALSO RECEIVED ION-SELECTIVE ELECTRODE (ISE) UNSTABLE AND SOLUTION ERRORS.