NA ELECTRODE
Received Feb 4, 2025 · Event occurred Jan 15, 2025
Report 1823260-2025-00328 · MDR key 21306840
Device
Generic name
Electrode, Ion Specific, Sodium
Manufacturer
Roche DiagnosticsCatalog number
10825468001
Lot number
ASKU
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
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE SODIUM RESULT FROM THE COBAS 8000 COBAS ISE MODULE (DOUBLE). THE SAMPLE WAS REPEATED BECAUSE THE DOCTOR QUESTIONED THE RESULTS. THE INITIAL RESULT WAS 121 MMOL/L. THE REPEAT RESULT FROM THE OTHER ISE MODULE WAS 129 MMOL/L. THIS RESULT WAS BELIEVED TO BE CORRECT.
Additional Manufacturer Narrative
THE COBAS 8000 COBAS ISE MODULE (DOUBLE) SERIAL NUMBER WAS (B)(6). THE CALIBRATION AND QC PRIOR TO THE EVENT WAS ACCEPTABLE. THE FIELD SERVICE ENGINEER CHECKED THE ANALYZER AND COULD NOT DETERMINE A CAUSE. HE REPLACED THE VACUUM NOZZLE AND A VALVE, ADJUSTED THE SIPPER NOZZLE VERTICAL ALIGNMENT INSIDE THE DILUTION VESSEL, AND PERFORMED ISE CHECKS. HE PERFORMED SUCCESSFUL CALIBRATIONS AND QC THAT WERE WITHIN RANGE. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
AS THE CUSTOMER WAS UNABLE TO PROVIDE FURTHER INFORMATION, THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.