SODIUM ELECTRODE

Additional Manufacturer Narrative

THE ANALYZER ALARM TRACE CONTAINED ABNORMAL ASPIRATION AND SAMPLE SHORT ERRORS FOR THE SAMPLE PROBE. THESE ARE INDICATORS OF POSSIBLE POOR SAMPLE QUALITY. THE PROVIDED CENTRIFUGATION SPIN TIME MAY BE SHORTER THAN RECOMMENDED, AND THE SPIN SPEED MAY BE FASTER THAN RECOMMENDED ACCORDING TO THE TUBE MANUFACTURER¿S RECOMMENDED GUIDELINES. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THE INVESTIGATION DETERMINED THAT THE ISSUE WAS RESOLVED BY SERVICE ACTIONS OF RECALIBRATION AND PROBE CLEANING.

Additional Manufacturer Narrative

THE COBAS PRO ISE ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE FIELD SERVICE ENGINEER FOUND THERE WAS A BAD CALIBRATION. HE RECALIBRATED THE ISE ASSAYS, AND THE CUSTOMER CLEANED THE SAMPLE PROBE. HE RAN MECHANISM CHECKS, CALIBRATION, QC, AND PRECISION, WHICH WERE SUCCESSFUL AND WITHIN SPECIFICATIONS. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM RESULTS FROM THE COBAS PRO ISE ANALYTICAL UNIT. THE SAMPLES WERE REPEATED ON ANOTHER COBAS PRO ISE ANALYZER WITH RESULTS IN THE NORMAL RANGE. SAMPLE 1 INITIAL RESULT WAS 132 MMOL/L, AND THE REPEAT RESULT WAS 138.4 MMOL/L. SAMPLE 2 INITIAL RESULT WAS 133 MMOL/L, AND THE REPEAT RESULT WAS 139.3 MMOL/L. SAMPLE 3 INITIAL RESULT WAS 131 MMOL/L, AND THE REPEAT RESULT WAS 137.8 MMOL/L. SAMPLE 4 INITIAL RESULT WAS 131 MMOL/L, AND THE REPEAT RESULT WAS 137.9 MMOL/L. SAMPLE 5 INITIAL RESULT WAS 125 MMOL/L, AND THE REPEAT RESULT WAS 131.8 MMOL/L. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.