NA ELECTRODE
Received May 22, 2024 · Event occurred Apr 29, 2024
Report 1823260-2024-01522 · MDR key 19371202
Device
Generic name
Electrode, Ion Specific, Sodium
Manufacturer
Roche DiagnosticsCatalog number
05641497001
Lot number
ASKU
Product problems
- High Test Results
- High Test 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 QUESTIONABLE GEN.2 ISE INDIRECT FOR NA RESULTS FOR 3 PATIENT SAMPLES ON A COBAS 8000 COBAS ISE MODULE. FOR SAMPLE 1, THE INITIAL NA RESULTS WERE 143 MMOL/L AND 142 MMOL/L. THE SAMPLE WAS REPEATED ON AN ISE 8000 ANALYZER AND THE RESULT WAS 136 MMOL/L. THE SAMPLE WAS REPEATED AGAIN ON AN C501 ANALYZER AND THE RESULT WAS 136 MMOL/L. FOR SAMPLE 2, THE INITIAL NA RESULT WAS 136 MMOL/L. THE SAMPLE WAS REPEATED TWICE ON AN ISE 8000 ANALYZER AND THE RESULTS WERE 131 MMOL/L AND 130 MMOL/L. THE SAMPLE WAS REPEATED AGAIN ON AN C501 ANALYZER AND THE RESULT WAS 133 MMOL/L. FOR SAMPLE 3, THE INITIAL NA RESULT WAS 137 MMOL/L. THE SAMPLE WAS REPEATED ON AN ISE 8000 ANALYZER AND THE RESULT WAS 131 MMOL/L. THE SAMPLE WAS REPEATED AGAIN ON AN C501 ANALYZER AND THE RESULT WAS 135 MMOL/L.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE CUSTOMER REPLACED THE NA ELECTRODE AND PERFORMED CORRELATION TESTING ON THE SAMPLES 1 AND 3 SUCCESSFULLY. THE REPLACEMENT OF THE NA ELECTRODE RESOLVED THE ISSUE.