COBAS 6000 C501MODULE

Description of Event or Problem

CUSTOMER STATES THEY ASSAYED A PT SAMPLE FOR CALCIUM AND RECOVERED RESULT OF 0.3 MG PER DL. THIS RESULT WAS ACCOMPANIED BY A DATA FLAG NOTIFYING THE USER THE RESULT IS OUTSIDE THE TECHNICAL LIMIT OF THE ASSAY. THE ANALYZER AUTO RERAN THE SAMPLE AND RECOVERED 0.4 MG PER DL. THE TECHNICIAN REPORTED THE 0.4 MG PER DL RESULT. ON (B)(6) 2009, THE PHYSICIAN QUESTIONED THE RESULT AND THE SAMPLE WAS PULLED AND RERUN. AT THAT TIME, THE RESULT RECOVERED WAS 9.9 MG PER DL. CUSTOMER STATES THE PT WAS REDRAWN AND THE SECOND SAMPLE RESULT WAS 9.6 MG PER DL. NO OTHER ASSAYS WERE AFFECTED. THE PT WAS NOT TREATED BASED ON THIS ERRONEOUS RESULT. THE FIELD SERVICE REPRESENTATIVE DID NOT FIND A CAUSE. HE PERFORMED A PRECISION ON CALCIUM AND SEVERAL OTHER TESTS TO VERIFY ANALYZER OPERATION. PRECISION RESULTS WERE GOOD ON ALL TESTS AND THE FIELD SERVICE REPRESENTATIVE OBSERVED PROPER ANALYZER MECHANICAL OPERATION.