TOTAL PROTEIN GEN.2

Description of Event or Problem

THE USER RECEIVED A QUESTIONABLE TOTAL PROTEIN RESULT FOR ONE PATIENT SAMPLE FROM THE COBAS C501 ANALYZER SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 0.3 G/DL AND WAS REPORTED OUTSIDE THE LABORATORY. WHEN THE USER RECEIVED ANOTHER SAMPLE FROM THE SAME PATIENT AND TESTED IT, THE SYSTEM ISSUED AN ALERT BECAUSE THE CURRENT RESULT DID NOT MATCH THE RESULT FROM THE PREVIOUS SAMPLE. THE USER PULLED THE ORIGINAL SAMPLE AND REPEATED TESTING ON (B)(6) 2011 WITH A RESULT OF 8.0 G/DL. PER LABORATORY PROTOCOL, THE USER FILED A CORRECTED REPORT. THE PATIENT WAS NOT ADVERSELY AFFECTED. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A FLUIDIC FAILURE DUE TO AN UNKNOWN MATERIAL FOUND FLOATING IN THE ORIGINAL SAMPLE TUBE. HE TAUGHT THE USER THE IMPORTANCE OF PRE-ANALYTIC SAMPLE HANDLING AND REPLACED THE SAMPLE PROBE AS A PREVENTIVE MEASURE. TO VERIFY THE ANALYZER OPERATION, THE USER RAN CALIBRATION, QUALITY CONTROL, AND PRECISION TESTING WITH RESULTS WITHIN THEIR SPECIFICATIONS.