SODIUM ELECTRODE
Received Nov 3, 2025 · Event occurred Oct 1, 2025
Report 1823260-2025-04465 · MDR key 23453684
Device
Generic name
Electrode, Ion Specific, Sodium
Manufacturer
Roche DiagnosticsCatalog number
10825468001
Lot number
ASKU
Product problems
- Low Test Results
- Insufficient Device Problem Information
- Low Test Results
- Insufficient Device Problem Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. DUE TO THE LACK OF INFORMATION PROVIDED, THE INVESTIGATION COULD NOT IDENTIFY A SPECIFIC CAUSE OF THE EVENT.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 ISE 1800 MODULE. THE INITIAL RESULT WAS 120.7 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER MODULE, AND THE RESULT WAS 136 MMOL/L. THIS RESULT WAS BELIEVED TO BE CORRECT. A DELTA CHECK IN THE CUSTOMER'S SYSTEM PROMPTED THE SAMPLE TO BE REPEATED.
Additional Manufacturer Narrative
THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE FIELD SERVICE REPRESENTATIVE PERFORMED CHECKS AND TESTS WITH ACCEPTABLE RESULTS. THE INVESTIGATION IS ONGOING.