Description of Event or Problem · 1
THE USER DISCOVERED QUESTIONABLE PHOSPHORUS RESULTS WHEN A DOCTOR QUESTIONED THE HIGH RESULT FOR ONE PATIENT SAMPLE. OF THE DATA PROVIDED, THE RESULTS FOR NINE PATIENT SAMPLES WERE DISCREPANT. THE REPEAT TESTING WAS PERFORMED ON ANALYTICAL P MODULE SERIAL NUMBER (B)(4). ALL RESULTS ARE IN MG/DL. PATIENT SAMPLE 1 INITIAL RESULT WAS 6.8, REPEAT RESULT WAS 3.0. PATIENT SAMPLE 2 INITIAL RESULT WAS 10.3, REPEAT RESULT WAS 3.7. PATIENT SAMPLE 3 INITIAL RESULT WAS 6.9, REPEAT RESULT WAS 3.8. PATIENT SAMPLE 4 INITIAL RESULT WAS 6.1, REPEAT RESULT WAS 3.1. PATIENT SAMPLE 5 INITIAL RESULT WAS 7.8, REPEAT RESULT WAS 3.6. PATIENT SAMPLE 6 INITIAL RESULT WAS 8.3, REPEAT RESULT WAS 4.2. PATIENT SAMPLE 7 INITIAL RESULT WAS 7.5, REPEAT RESULT WAS 3.4. PATIENT SAMPLE 8 INITIAL RESULT WAS 6.7, REPEAT RESULT WAS 3.5. PATIENT SAMPLE 9 INITIAL RESULT WAS 6.5, REPEAT RESULT WAS 3.4. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND CORRECTED REPORTS WERE SENT OUT. NO ONE WAS TREATED BECAUSE OF THE INITIAL RESULTS. THE PHOSPHORUS REAGENT LOT NUMBER WAS 62701801. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE VACUUM WAS WEAK AND REPLACED THE VACUUM DIAPHRAGM AND ALL THE VACUUM TUBING ON THE RINSE MECHANISMS. TO VERIFY THE ANALYZER OPERATION, THE USER RAN CALIBRATION AND QUALITY CONTROL WITH RESULTS WITHIN SPECIFICATION. THE FIELD SERVICE REPRESENTATIVE RAN PRECISION TESTING.