NA ELECTRODE

Additional Manufacturer Narrative

CALIBRATION WAS LAST PERFORMED ON (B)(6) 2024 WITH ACCEPTABLE RESULTS. QC WAS ACCEPTABLE. "ISE VOLTAGE LEVEL ERROR", "ABNORMAL SAMPLE PROBE MOVEMENT", "SAMPLE SHORT" AND "ABNORMAL SAMPLE ASPIRATION" ALARMS WERE OBSERVED ON THE ALARM TRACE DATA. THE CUSTOMER DECLINED A SERVICE VISIT. THEY RESOLVED THE ISSUE BY REMOVING A COVER THAT WAS BLOCKING THE FLOW PATH. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE C501 MODULE SERIAL NUMBER WAS (B)(6).

Description of Event or Problem

THE INITIAL REPORTER STATED THEY WERE RECEIVING "A LOT" OF DELTA CHECKS FOR PATIENT SAMPLES TESTED FOR NA ELECTRODE (NA) ON A COBAS 6000 C (501) MODULE. THE ELECTRODES WERE REPLACED AND PATIENT SAMPLES WERE REPEATED ON A DIFFERENT C501 MODULE. THE RESULTS FOR 22 PATIENT SAMPLES WERE REPORTEDLY CORRECTED. EXAMPLES OF DISCREPANT RESULTS WERE PROVIDED FOR 2 PATIENT SAMPLES. PATIENT (B)(6) INITIAL RESULT WAS 131 MMOL/L. THE REPEAT RESULT WAS 140 MMOL/L. PATIENT (B)(6) INITIAL RESULT WAS 122 MMOL/L. THE REPEAT RESULT WAS 130 MMOL/L. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.