NA ELECTRODE
Received Jan 13, 2025 · Event occurred Dec 25, 2024
Report 1823260-2025-00113 · MDR key 21139024
Device
Generic name
Electrode, Ion Specific, Sodium
Manufacturer
Roche DiagnosticsCatalog number
10825468001
Lot number
ASKU
Product problems
- Incorrect Measurement
- Insufficient Device Problem Information
- Non Reproducible Results
- Incorrect Measurement
- Insufficient Device Problem Information
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ELECTRODE LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS 6000 C 501 ANALYZER. PATIENT 1 INITIAL SODIUM RESULT WAS 113 MMOL/L AND THE REPEAT RESULT WAS 124 MMOL/L AND ON ANOTHER ANALYZER WAS 126 MMOL/L. PATIENT 2 INITIAL SODIUM RESULT WAS 98 MMOL/L AND THE REPEAT RESULT WAS 134 MMOL/L. THE INITIAL CHLORIDE RESULT WAS 131.9 MMOL/L AND THE REPEAT RESULT WAS 95.9 MMOL/L. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.
Additional Manufacturer Narrative
MEDWATCH FIELDS D1-D4, G1, AND G4 WERE UPDATED. THE FIELD SERVICE ENGINEER CHECKED THE ANALYZER AND COULD NOT ESTABLISH A CAUSE. HE DECONTAMINATED THE ISE SYSTEMS AND REPLACED THE ELECTRODES AND THE ISE REAGENT. HE RAN PASSING ISE CHECKS, PASSING ISE CALIBRATION, AND PASSING ISE PRECISION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED.