D
Patient 1
THE USER STATED THEIR RESULTS DID NOT COMPARE WELL WITH THE PEER GROUP RESULTS FOR A THERAPEUTIC DRUG LINEARITY SURVEY. OF THE DATA PROVIDED, THE CARBAMAZEPINE RESULTS FOR THREE SAMPLES, THE VANCOMYCIN RESULTS FOR FIVE SAMPLES AND THE VALPROIC ACID RESULTS FOR FOUR SAMPLE WERE DISCREPANT. ALL RESULTS ARE IN UG/ML. THE CARBAMAZEPINE RESULTS WERE: SAMPLE 1 : 7.7 AND 7.8 FOR A MEAN OF 7.75, THE PEER MEAN WAS 9.37. SAMPLE 2: 11.0 AND 10.9 FOR A MEAN OF 10.95, THE PEER WAS 12.82. SAMPLE 3: 14.0 AND 13.7 FOR A MEAN OF 13.85, THE PEER MEAN WAS 15.96. THE VANCOMYCIN RESULTS WERE: SAMPLE 1: RESULTS WERE 4.3 AND 4.6 FOR A MEAN OF 4.45, THE PEER MEAN WAS 3.25. SAMPLE 2: RESULTS WERE 50.5 AND 50.6 FOR A MEAN OF 50.55, THE PEER MEAN WAS 41.27. SAMPLE 3: RESULTS WERE 72.9 AND 72.7 FOR A MEAN OF 72.80, THE PEER MEAN WAS 60.43. SAMPLE 4: RESULTS WERE 92.0 AND 91.7 FOR A MEAN OF 91.87, THE PEER MEAN WAS 76.65. SAMPLE 5: RESULTS WERE 117.7 AND 114.3 FOR A MEAN OF 116.00, THE PEER MEAN WAS 90.65. THE VALPROIC ACID RESULTS WERE: SAMPLE 1: RESULTS WERE 73.4 AND 78.0 FOR A MEAN OF 75.70, THE PEER MEAN WAS 70.89. SAMPLE 2: RESULTS WERE 99.6 AND 97.2 FOR A MEAN OF 98.40, THE PEER MEAN WAS 98.80. SAMPLE 3: RESULTS WERE 120.1 AND 112.0 FOR A MEAN OF 116.05, THE PEER MEAN WAS 125.80. SAMPLE 4: RESULTS WERE 141.6 AND 153.8 FOR A MEAN OF 147.70, THE PEER MEAN WAS 147.13. THE SAMPLES WERE TESTED IN MICROCUPS. THE CARBAMAZEPINE REAGENT LOT NUMBER WAS 584903, THE VANCOMYCIN REAGENT LOT NUMBER WAS 14455000 AND THE VALPROIC ACID LOT NUMBER WAS 14454900. THE USER RETESTED THE SAME SAMPLES ON (B) (6) 2010 AND (B) (6) 2010 WITH NEW LOT NUMBERS OF REAGENTS AND RESULTS WERE WITHIN THE ACCEPTABLE RANGE. THE CARBAMAZEPINE REAGENT LOT NUMBER 587925. THE VANCOMYCIN AND VALPROIC ACID LOT NUMBER WERE NOT PROVIDED. THE CARBAMAZEPINE REPEAT RESULTS WERE: SAMPLE 1 : 9.714 AND 9.770. SAMPLE 2: 13.305 AND 13.363. SAMPLE 3: 16.381 AND 17.139. THE VANCOMYCIN RESULTS WERE: SAMPLE 1: 4.7 AND 5.1. SAMPLE 2: 41.6, 42.3 AND ON (B) (6) 2010 WAS 40.4. SAMPLE 3: 61.2, 61.3 AND ON (B) (6) 2010 WAS 57.0. SAMPLE 4: 78.2, 79.9 AND ON (B) (6) 2010 WAS 71.6. SAMPLE 5: 96.5 WITH A DATA FLAG, 100.3 WITH A DATA FLAG AND ON (B) (6) 2010 WAS 86.3. THE VALPROIC ACID RESULTS WERE: SAMPLE 1: 89.8, 92.0 AND ON (B) (6) 2010 WAS 77.0. SAMPLE 2: 123.0, 125.0 AND ON (B) (6) 2010 WAS 103.4. SAMPLE 3: 164.9 WITH A DATA FLAG, 171.9 WITH A DATA FLAG AND ON (B) (6) 2010 WAS 120.9. SAMPLE 4: 196.5 WITH A DATA FLAG, 171.9 WITH A DATA FLAG AND ON (B) (6) 2010 WAS 143.5. THE USER STATED NO PATIENT SAMPLES WERE AFFECTED BY THE ISSUE. THE USER STATED HE FELT THE CAUSE MAY BE A REAGENT ISSUE OR A POOR CALIBRATION. THE FIELD APPLICATION SPECIALIST CALIBRATED THE ASSAYS WITH A NEW CALIBRATOR AND RECOVERED QC VALUES CLOSE TO THE MEAN. HE THEN RETESTED THE LINEARITY MATERIAL AND RESULTS RECOVERED IN RANGE.