SODIUM ELECTRODE
Received Oct 21, 2025 · Event occurred Sep 28, 2025
Report 1823260-2025-04271 · MDR key 23346406
Device
Generic name
Electrode, Ion Specific, Sodium
Manufacturer
Roche DiagnosticsCatalog number
10825468001
Lot number
DVL92
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
79 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS PRO ISE ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE FIELD SERVICE ENGINEER INSPECTED THE ANALYZER, PERFORMED A FULL SYSTEM MECHANICAL AND FLUID CHECK, AND VERIFIED THAT THE ANALYZER WAS PERFORMING ACCORDING TO SPECIFICATIONS. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE SODIUM ELECTRODE RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PRO ISE ANALYTICAL UNIT. THE INITIAL NA RESULT WAS 152.7 MMOL/L. THE REPEAT RESULT WAS 143.3 MMOL/L. THE EMERGENCY DEPARTMENT (ED) PERSONNEL QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S HISTORY, PROMPTING THE RERUN OF THE PATIENT SAMPLE. THE REPEAT RESULT WAS DEEMED CORRECT.
Additional Manufacturer Narrative
THE INVESTIGATION INCLUDED A REVIEW OF THE DATA SET PROVIDED BY THE CUSTOMER: THE CALIBRATION RESULTS WERE WITHIN THE SPECIFIED RANGES. THE QC LEVELS 1 AND 3 RESULTS WERE WITHIN THE SPECIFIED RANGES. THE PATIENT SAMPLE WAS CENTRIFUGED FOR 3 MINUTES. THE CUSTOMER DID NOT REPORT ANY OTHER ISSUES AFTER THE SERVICE. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.