Description of Event or Problem · 1
THE CUSTOMER RECEIVED QUESTIONABLE ISE RESULTS DURING A RUN OF PATIENT SAMPLES. SHE REPEATED THE SAMPLES ON THE SAME ANALYZER AND PROVIDED 90 DISCREPANT SODIUM PATIENT RESULTS. SAMPLE 1, INITIAL RESULT WAS 139 MEQ/L. THE REPEAT RESULT WAS 133 MEQ/L. SAMPLE 2, INITIAL RESULT WAS 138 MEQ/L. THE REPEAT RESULT WAS 132 MEQ/L. SAMPLE 3, INITIAL RESULT WAS 140 MEQ/L. THE REPEAT RESULT WAS 134 MEQ/L. SAMPLE 4, INITIAL RESULT WAS 146 MEQ/L. THE REPEAT RESULT WAS 140 MEQ/L. SAMPLE 5, INITIAL RESULT WAS 154 MEQ/L. THE REPEAT RESULT WAS 148 MEQ/L. SAMPLE 6, INITIAL RESULT WAS 146 MEQ/L. THE REPEAT RESULT WAS 140 MEQ/L. SAMPLE 7, INITIAL RESULT WAS 148 MEQ/L. THE REPEAT RESULT WAS 142 MEQ/L. SAMPLE 8, INITIAL RESULT WAS 147 MEQ/L. THE REPEAT RESULT WAS 141 MEQ/L. SAMPLE 9, INITIAL RESULT WAS 146 MEQ/L. THE REPEAT RESULT WAS 140 MEQ/L. SAMPLE 10, INITIAL RESULT WAS 150 MEQ/L. THE REPEAT RESULT WAS 144 MEQ/L. SAMPLE 11, INITIAL RESULT WAS 148 MEQ/L. THE REPEAT RESULT WAS 142 MEQ/L. SAMPLE 12, INITIAL RESULT WAS 147 MEQ/L. THE REPEAT RESULT WAS 141 MEQ/L. SAMPLE 13, INITIAL RESULT WAS 148 MEQ/L. THE REPEAT RESULT WAS 142 MEQ/L. SAMPLE 14, INITIAL RESULT WAS 150 MEQ/L. THE REPEAT RESULT WAS 144 MEQ/L. SAMPLE 15, INITIAL RESULT WAS 147 MEQ/L. THE REPEAT RESULT WAS 141 MEQ/L. SAMPLE 16, INITIAL RESULT WAS 140 MEQ/L. THE REPEAT RESULT WAS 134 MEQ/L. SAMPLE 17, INITIAL RESULT WAS 148 MEQ/L. THE REPEAT RESULT WAS 141 MEQ/L. SAMPLE 18, INITIAL RESULT WAS 149 MEQ/L. THE REPEAT RESULT WAS 142 MEQ/L. SAMPLE 19, INITIAL RESULT WAS 147 MEQ/L. THE REPEAT RESULT WAS 140 MEQ/L. SAMPLE 20, INITIAL RESULT WAS 147 MEQ/L. THE REPEAT RESULT WAS 140 MEQ/L. SAMPLE 21, INITIAL RESULT WAS 148 MEQ/L. THE REPEAT RESULT WAS 141 MEQ/L. SAMPLE 22, INITIAL RESULT WAS 149 MEQ/L. THE REPEAT RESULT WAS 142 MEQ/L. SAMPLE 23, INITIAL RESULT WAS 148 MEQ/L. THE REPEAT RESULT WAS 141 MEQ/L. SAMPLE 24, INITIAL RESULT WAS 152 MEQ/L. THE REPEAT RESULT WAS 145 MEQ/L. SAMPLE 25, INITIAL RESULT WAS 149 MEQ/L. THE REPEAT RESULT WAS 142 MEQ/L. SAMPLE 26, INITIAL RESULT WAS 149 MEQ/L. THE REPEAT RESULT WAS 142 MEQ/L. SAMPLE 27, INITIAL RESULT WAS 140 MEQ/L. THE REPEAT RESULT WAS 133 MEQ/L. SAMPLE 28, INITIAL RESULT WAS 149 MEQ/L. THE REPEAT RESULT WAS 142 MEQ/L. SAMPLE 29, INITIAL RESULT WAS 148 MEQ/L. THE REPEAT RESULT WAS 141 MEQ/L. SAMPLE 30, INITIAL RESULT WAS 150 MEQ/L. THE REPEAT RESULT WAS 143 MEQ/L. SAMPLE 31, INITIAL RESULT WAS 146 MEQ/L. THE REPEAT RESULT WAS 139 MEQ/L. SAMPLE 32, INITIAL RESULT WAS 149 MEQ/L. THE REPEAT RESULT WAS 142 MEQ/L. SAMPLE 33, INITIAL RESULT WAS 148 MEQ/L. THE REPEAT RESULT WAS 141 MEQ/L. SAMPLE 34, INITIAL RESULT WAS 156 MEQ/L. THE REPEAT RESULT WAS 148 MEQ/L. SAMPLE 35, INITIAL RESULT WAS 150 MEQ/L. THE REPEAT RESULT WAS 142 MEQ/L. SAMPLE 36, INITIAL RESULT WAS 148 MEQ/L. THE REPEAT RESULT WAS 140 MEQ/L. SAMPLE 37, INITIAL RESULT WAS 149 MEQ/L. THE REPEAT RESULT WAS 141 MEQ/L. SAMPLE 38, INITIAL RESULT WAS 147 MEQ/L. THE REPEAT RESULT WAS 139 MEQ/L. SAMPLE 39, INITIAL RESULT WAS 155 MEQ/L. THE REPEAT RESULT WAS 147 MEQ/L. SAMPLE 40, INITIAL RESULT WAS 146 MEQ/L. THE REPEAT RESULT WAS 138 MEQ/L. SAMPLE 41, INITIAL RESULT WAS 149 MEQ/L. THE REPEAT RESULT WAS 141 MEQ/L. SAMPLE 42, INITIAL RESULT WAS 149 MEQ/L. THE REPEAT RESULT WAS 141 MEQ/L. SAMPLE 43, INITIAL RESULT WAS 150 MEQ/L. THE REPEAT RESULT WAS 142 MEQ/L. SAMPLE 44, INITIAL RESULT WAS 150 MEQ/L. THE REPEAT RESULT WAS 142 MEQ/L. SAMPLE 45, INITIAL RESULT WAS 142 MEQ/L. THE REPEAT RESULT WAS 134 MEQ/L. SAMPLE 46, INITIAL RESULT WAS 149 MEQ/L. THE REPEAT RESULT WAS 141 MEQ/L. SAMPLE 47, INITIAL RESULT WAS 151 MEQ/L. THE REPEAT RESULT WAS 143 MEQ/L. SAMPLE 48, INITIAL RESULT WAS 156 MEQ/L. THE REPEAT RESULT WAS 148 MEQ/L. SAMPLE 49, INITIAL RESULT WAS 151 MEQ/L. THE REPEAT RESULT WAS 143 MEQ/L. SAMPLE 50, INITIAL RESULT WAS 146 MEQ/L. THE REPEAT RESULT WAS 138 MEQ/L. SAMPLE 51, INITIAL RESULT WAS 147 MEQ/L. THE REPEAT RESULT WAS 139 MEQ/L. SAMPLE 52, INITIAL RESULT WAS 135 MEQ/L. THE REPEAT RESULT WAS 127 MEQ/L. SAMPLE 53, INITIAL RESULT WAS 151 MEQ/L. THE REPEAT RESULT WAS 143 MEQ/L. SAMPLE 54, INITIAL RESULT WAS 152 MEQ/L. THE REPEAT RESULT WAS 143 MEQ/L. SAMPLE 55, INITIAL RESULT WAS 150 MEQ/L. THE REPEAT RESULT WAS 141 MEQ/L. SAMPLE 56, INITIAL RESULT WAS 143 MEQ/L. THE REPEAT RESULT WAS 134 MEQ/L. SAMPLE 57, INITIAL RESULT WAS 146 MEQ/L. THE REPEAT RESULT WAS 137 MEQ/L. SAMPLE 58, INITIAL RESULT WAS 139 MEQ/L. THE REPEAT RESULT WAS 130 MEQ/L. SAMPLE 59, INITIAL RESULT WAS 140 MEQ/L. THE REPEAT RESULT WAS 131 MEQ/L. SAMPLE 60, INITIAL RESULT WAS 149 MEQ/L. THE REPEAT RESULT WAS 140 MEQ/L. SAMPLE 61, INITIAL RESULT WAS 150 MEQ/L. THE REPEAT RESULT WAS 141 MEQ/L. SAMPLE 62, INITIAL RESULT WAS 151 MEQ/L. THE REPEAT RESULT WAS 142 MEQ/L. SAMPLE 63, INITIAL RESULT WAS 154 MEQ/L. THE REPEAT RESULT WAS 145 MEQ/L. SAMPLE 64, INITIAL RESULT WAS 143 MEQ/L. THE REPEAT RESULT WAS 134 MEQ/L. SAMPLE 65, INITIAL RESULT WAS 152 MEQ/L. THE REPEAT RESULT WAS 142 MEQ/L. SAMPLE 66, INITIAL RESULT WAS 147 MEQ/L. THE REPEAT RESULT WAS 137 MEQ/L. SAMPLE 67, INITIAL RESULT WAS 149 MEQ/L. THE REPEAT RESULT WAS 139 MEQ/L. SAMPLE 68, INITIAL RESULT WAS 150 MEQ/L. THE REPEAT RESULT WAS 140 MEQ/L. SAMPLE 69, INITIAL RESULT WAS 144 MEQ/L. THE REPEAT RESULT WAS 134 MEQ/L. SAMPLE 70, INITIAL RESULT WAS 149 MEQ/L. THE REPEAT RESULT WAS 139 MEQ/L. SAMPLE 71, INITIAL RESULT WAS 146 MEQ/L. THE REPEAT RESULT WAS 136 MEQ/L. SAMPLE 72, INITIAL RESULT WAS 151 MEQ/L. THE REPEAT RESULT WAS 141 MEQ/L. SAMPLE 73, INITIAL RESULT WAS 147 MEQ/L. THE REPEAT RESULT WAS 137 MEQ/L. SAMPLE 74, INITIAL RESULT WAS 152 MEQ/L. THE REPEAT RESULT WAS 142 MEQ/L. SAMPLE 75, INITIAL RESULT WAS 151 MEQ/L. THE REPEAT RESULT WAS 141 MEQ/L. SAMPLE 76, INITIAL RESULT WAS 147 MEQ/L. THE REPEAT RESULT WAS 136 MEQ/L. SAMPLE 77, INITIAL RESULT WAS 149 MEQ/L. THE REPEAT RESULT WAS 138 MEQ/L. SAMPLE 78, INITIAL RESULT WAS 152 MEQ/L. THE REPEAT RESULT WAS 141 MEQ/L. SAMPLE 79, INITIAL RESULT WAS 151 MEQ/L. THE REPEAT RESULT WAS 140 MEQ/L. SAMPLE 80, INITIAL RESULT WAS 147 MEQ/L. THE REPEAT RESULT WAS 136 MEQ/L. SAMPLE 81, INITIAL RESULT WAS 153 MEQ/L. THE REPEAT RESULT WAS 142 MEQ/L. SAMPLE 82, INITIAL RESULT WAS 153 MEQ/L. THE REPEAT RESULT WAS 142 MEQ/L. SAMPLE 83, INITIAL RESULT WAS 149 MEQ/L. THE REPEAT RESULT WAS 138 MEQ/L. SAMPLE 84, INITIAL RESULT WAS 152 MEQ/L. THE REPEAT RESULT WAS 141 MEQ/L. SAMPLE 85, INITIAL RESULT WAS 150 MEQ/L. THE REPEAT RESULT WAS 138 MEQ/L. SAMPLE 86, INITIAL RESULT WAS 151 MEQ/L. THE REPEAT RESULT WAS 139 MEQ/L. SAMPLE 87, INITIAL RESULT WAS 151 MEQ/L. THE REPEAT RESULT WAS 139 MEQ/L. SAMPLE 88, INITIAL RESULT WAS 154 MEQ/L. THE REPEAT RESULT WAS 142 MEQ/L. SAMPLE 89, INITIAL RESULT WAS 153 MEQ/L. THE REPEAT RESULT WAS 141 MEQ/L. SAMPLE 90, INITIAL RESULT WAS 154 MEQ/L. THE REPEAT RESULT WAS 141 MEQ/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. NO ADVERSE EVENTS HAVE BEEN ALLEGED REGARDING THE DISCREPANCIES. THE SODIUM ELECTRODE LOT NUMBER WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE SAMPLE PROBE WAS THE CAUSE OF THE DISCREPANCIES AND HE REPLACED THE SAMPLE PROBE. HE ALSO CHECKED THE VACUUM PUMP DIAPHRAM AND ISE LINES WHICH WERE OK. THE FIELD SERVICE REPRESENTATIVE RAN PERFORMANCE TESTS, INCLUDING QUALITY CONTROL, WHICH WERE ACCEPTABLE.