Description of Event or Problem · 1
CUSTOMER EXPERIENCED ISE REPRODUCIBILITY PROBLEMS FOR APPROXIMATELY ONE WEEK. SHE PROVIDED SODIUM RESULTS FOR TWO PATIENT SAMPLES, REPEAT TESTING PERFORMED ON SAME ANALYZER: PATIENT 1, PLASMA SAMPLE, INITIAL SODIUM RESULT 135 MMOL/L, REPEATED 11 TIMES GAVE: 130 (ACCOMPANIED BY L DATA FLAG), 132 (ACCOMPANIED BY L DATA FLAG), 139, 136, 134, 133, 140, 134, 133 (ACCOMPANIED BY L DATA FLAG), 132 (ACCOMPANIED BY L DATA FLAG) AND 134 MMOL/L. PATIENT 1, SERUM SAMPLE DRAWN AT SAME TIME AS PLASMA SAMPLE, INITIAL SODIUM RESULT 141 MMOL/L, REPEATED 4 TIMES GAVE 140 MMOL/L EACH TIME. PATIENT 2, MALE, (B)(6), INITIAL SODIUM RESULT 134 MMOL/L, REPEATED 5 TIMES GAVE 140, 137, 138, 139 AND 138 MMOL/L. THE INITIAL SODIUM RESULTS WERE NOT REPORTED, THE PATIENTS WERE NOT AFFECTED. SODIUM ELECTRODED LOT # WAS 21593518. THE FIELD SERVICE REPRESENTATIVE FOUND THE CAUSE WAS PRESSURE FAILURE DUE TO MISADJUSTED AIR MIX/AIR DRY ON ISE UNIT. HE ADJUSTED AIR MIX/AIR DRY. THE CUSTOMER RAN CALIBRATION AND QC WHICH WAS WITHIN CUSTOMER'S SPECIFICATION.