SODIUM ELECTRODE
Received Aug 26, 2024 · Event occurred Aug 2, 2024
Report 1823260-2024-02478 · MDR key 20069122
Device
Generic name
Electrode, Ion Specific, Sodium
Manufacturer
Roche DiagnosticsCatalog number
21029371001
Lot number
ASKU
Product problems
- Low Test Results
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INTEGRA 400 PLUS ANALYZER SERIAL NUMBER WAS (B)(6).
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF LOW RESULTS FOR AN UNSPECIFIED NUMBER OF PATENT SAMPLES TESTED FOR SODIUM ELECTRODE (NA) ON A COBAS INTEGRA 400 PLUS ANALYZER. AN EXAMPLE OF DISCREPANT RESULTS WAS PROVIDED FOR 1 PATIENT SAMPLE. THE RESULT FROM THE INTEGRA 400 PLUS ANALYZER WAS 133 MMOL/L. THE RESULT FROM THE CUSTOMER'S COBAS 6000 SYSTEM WAS 140 MMOL/L.
Additional Manufacturer Narrative
THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION FOR THE INVESTIGATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.