NA ELECTRODE

Additional Manufacturer Narrative

CALIBRATION AND QC DATA PRIOR TO PATIENT SAMPLE MEASUREMENT WERE ACCEPTABLE. THE SAMPLE CENTRIFUGATION SPEED MAY HAVE BEEN SHORTER THAN RECOMMENDED BY THE TUBE MANUFACTURER. UPON REVIEW OF THE ALARM TRACE, AN ABNORMAL ASPIRATION ERROR WAS OBSERVED. THIS IS AN INDICATOR OF POSSIBLE POOR SAMPLE QUALITY. THE CUSTOMER DECLINED A SERVICE VISIT. THE INVESTIGATION DETERMINED THE ISSUE WAS RESOLVED BY THE CUSTOMER REPLACEMENT OF THE NA ELECTRODE AND REFERENCE ELECTRODE.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE COBAS 8000 ISE MODULE IS (B)(6). THE CUSTOMER REPLACED THE NA ELECTRODE AND REFERENCE ELECTRODE. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE CUSTOMER STATED THEY RECEIVED QUESTIONABLE ISE RESULTS FOR APPROXIMATELY 19 PATIENT SAMPLES TESTED ON A COBAS 8000 ISE MODULE. THE SAMPLES WERE REPEATED AND 11 SAMPLE RESULTS NEEDED CORRECTION. THE CUSTOMER NOTED THEY REPLACED THE ISE ELECTRODES AND AFTER THIS, ALL CONTROLS WERE OUTSIDE OF RANGE. ISE CHECKS WERE ALSO FAILING. THE CUSTOMER TRIED RUNNING CLEANING MAINTENANCE, CONDITIONING THE ELECTRODES, REPLACING SYSTEM REAGENTS, AND REPLACING THE PINCH VALVE TUBING. THE CUSTOMER PROVIDED AN EXAMPLE OF ONE PATIENT SAMPLE WITH DISCREPANT NA ELECTRODE RESULTS. THE SAMPLE INITIALLY RESULTED IN A NA VALUE OF 133 MMOL/L. CONTROLS TESTED AFTER THE PATIENT SAMPLE RUN WERE OUTSIDE OF RANGE, SO THIS PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED, RESULTING IN A NA VALUE OF 141 MMOL/L. THE REPEAT VALUE WAS DEEMED CORRECT.