COBAS 6000 C501MODULE

Description of Event or Problem

THE USER RECEIVED QUESTIONABLE RESULTS FOR ALBUMIN GENERATION 2 (ALBUMIN), ALKALINE PHOSPHATASE GENERATION 2 AND UREA/BUN INVOLVING THREE PATIENT SAMPLES. OF THE DATA PROVIDED, ONLY THE ALBUMIN RESULT FOR ONE PATIENT SAMPLE WAS DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. THE INITIAL ALBUMIN RESULT WAS 0.1 G/DL WITH A DATA FLAG AND WAS REPORTED OUTSIDE THE LABORATORY. THE DOCTOR QUESTIONED THE RESULT AND THE REPEAT RESULT WAS 2.5 G/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED ON ANOTHER COBAS C501 SERIAL NUMBER (B)(4) AND THE RESULT WAS 2.6 G/DL WITH A DATA FLAG. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE ALBUMIN REAGENT LOT NUMBER WAS 63305101. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE SAMPLE PROBE WAS NOT BEING WASHED PROPERLY AND WAS NOT CENTERED IN RINSE STATION. HE PERFORMED A SAMPLE PROBE ADJUST AND ALIGNED RINSE STATION. TO VERIFY THE ANALYZER OPERATION, THE USER RAN QUALITY CONTROL ON ALL ASSAYS WITH RESULTS WITHIN SPECIFICATIONS.