Description of Event or Problem · 1
USER EXPERIENCED INTERMITTENT DISCREPANT TOTAL PSA RESULTS, APPROXIMATELY ONE PER DAY FOR SEVERAL DAYS. TODAY THERE WERE APPROXIMATELY ELEVEN PATIENTS INVOLVED. ONLY THREE PATIENT EXAMPLES WERE PROVIDED. PATIENT 1, INITIAL RESULT <0.1 NG/ML, REPEAT 1.1 NG/ML. PATIENT 2, INITIAL RESULT <0.1 NG/ML, REPEATED TWICE GAVE 23.0 NG/ML BOTH TIMES. PATIENT 3, INITIAL RESULT <0.1 NG/ML, REPEAT 6.6 NG/ML. INITIAL RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED A BENT MIXER PADDLE TO BE THE CAUSE AND STRAIGHTENED OUT MIXER PADDLE. HE ALSO PERFORMED ALL MIXER, S/R PROBE, SIPPER PROBE RACK SAMPLER AND GRIPPER ADJUSTMENTS. ADDITIONALLY, THE FIELD SERVICE REPRESENTATIVE NOTED CUSTOMER WAS USING 13 MM TUBES AND ADVISED CUSTOMER TO USE RACK CUP ADAPTERS IN RACKS FOR MORE CONSISTENT SAMPLING. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.