NA ELECTRODE
Received Dec 16, 2024 · Event occurred Nov 23, 2024
Report 1823260-2024-03700 · MDR key 20945057
Device
Generic name
Electrode, Ion Specific, Sodium
Manufacturer
Roche DiagnosticsCatalog number
10825468001
Lot number
AKY70
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
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. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE NA ELECTRODE RESULTS FOR 2 PATIENT SAMPLE(S) ON A COBAS PRO ISE ANALYTICAL UNIT. PATIENT 1: THE INITIAL NA RESULT WAS 147.4 MMOL/L AND THE REPEATED RESULT WAS 139.1 MMOL/L. PATIENT 2: THE INITIAL NA RESULT WAS 143.8 MMOL/L AND THE REPEATED RESULT WAS 134.4 MMOL/L. THE REPEATED RESULTS WERE OBTAINED ON ANOTHER MODULE AND WERE BELIEVED TO BE CORRECT. THE SAMPLES WERE REPEATED DUE TO A DELTA CHECK IN THE CUSTOMER'S SYSTEM.
Additional Manufacturer Narrative
THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE FIELD SERVICE REPRESENTATIVE INSPECTED/CHECKED THE INSTRUMENT AND VERIFIED IT WAS PERFORMING WITHIN SPECIFICATIONS. NO ABNORMALITIES WERE OBSERVED WITH THE INSTRUMENT. HE REPLACED THE ELECTRODES AND PERFORMED TESTS WITH ACCEPTABLE RESULTS. THE INVESTIGATION IS ONGOING.