COBAS 6000 C501 MODULE

Description of Event or Problem

THE USER RECEIVED QUESTIONABLE RESULTS FOR TOTAL PROTEIN GENERATION 2 (TP2) ON THE COBAS C501 ANALYZER. THE EVENT INVOLVED 7 PATIENT SAMPLES WHICH GAVE DISCREPANT RESULTS. THE PATIENT SAMPLES WERE REPEATED ON (B)(6) 2010 AND WERE RUN ON A DIFFERENT C501 ANALYZER SERIAL NUMBER (B)(4). PATIENT SAMPLE 1, THE INITIAL RESULT WAS 2.3 G/DL; THE REPEAT RESULT WAS 8.4 G/DL. PATIENT SAMPLE 2, THE INITIAL RESULT WAS 2.3 G/DL; THE REPEAT RESULT WAS 7.7 G/DL. PATIENT SAMPLE 3, THE INITIAL RESULT WAS 2.3 G/DL; THE REPEAT RESULT WAS 6.7 G/DL. PATIENT SAMPLE 4, THE INITIAL RESULT WAS 2.4 G/DL; THE REPEAT RESULT WAS 8.3 G/DL. PATIENT SAMPLE 5, THE INITIAL RESULT WAS 2.4 G/DL; THE REPEAT RESULT WAS 5.4 G/DL. PATIENT SAMPLE 6, THE INITIAL RESULT WAS 2.3 G/DL; THE REPEAT RESULT WAS 5.7 G/DL. PATIENT SAMPLE 7, THE INITIAL RESULT WAS 2.4 G/DL; THE REPEAT RESULT WAS 7.4 G/DL. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY TO THE PHYSICIANS AND REQUIRED CORRECTED REPORTS TO BE GENERATED. THE PATIENTS DID NOT RECEIVE ANY TREATMENT AND WERE NOT AFFECTED BY THIS EVENT. THE REAGENT LOT NUMBER FOR TP2 WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND AN ISSUE WITH THE GEAR PUMP. HE ADJUSTED GEAR PUMP PRESSURES. PERFORMANCE TESTS WERE RUN WHICH WERE ACCEPTABLE.