COBAS 6000 C501MODULE

Description of Event or Problem

THEN USER RECEIVED QUESTIONABLE HIGH PHOSPHORUS RESULTS FOR PATIENT SAMPLES THAT WERE DISCOVERED WHEN A DOCTOR CALLED QUESTIONING THE RESULTS. THE SAMPLES WERE REPEATED ON COBAS C501 ANALYZER SERIAL NUMBER (B)(4) AND THOSE RESULTS WERE CONSIDERED CORRECT. OF THE DATA PROVIDED, THE RESULTS FOR NINE PATIENT SAMPLES WERE DISCREPANT. ALL RESULTS ARE IN MG/DL. PATIENT SAMPLE 1 INITIAL RESULT WAS 5.6 AND THE REPEAT RESULT WAS 3.3. PATIENT SAMPLE 2 INITIAL RESULT WAS 5.5 AND THE REPEAT RESULT WAS 3.6. PATIENT SAMPLE 3 INITIAL RESULT WAS 3.1 AND THE REPEAT RESULT WAS 2.1. PATIENT SAMPLE 4 INITIAL RESULT WAS 3.5 AND THE REPEAT RESULT WAS 2.5. PATIENT SAMPLE 5 INITIAL RESULT WAS 6.4 AND THE REPEAT RESULT WAS 3. PATIENT SAMPLE 6 INITIAL RESULT WAS 8.6 AND THE REPEAT RESULT WAS 3.6. PATIENT SAMPLE 7 INITIAL RESULT WAS 6.5 AND THE REPEAT RESULT WAS 4.8. PATIENT SAMPLE 8 INITIAL RESULT WAS 6.1 AND THE REPEAT RESULT WAS 2.4. PATIENT SAMPLE 9 INITIAL RESULT WAS 1.7 AND THE REPEAT RESULT WAS 1.3. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. NO PATIENTS WERE ADVERSELY AFFECTED. THE PHOSPHORUS REAGENT LOT NUMBER WAS 64166101 WITH AN EXPIRATION DATE OF 07/31/2012. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A FLUIDICS FAILURE. HE REPLACED VALVE BLOCKS, DECONTAMINATED THE SYSTEM AND RINSE TUBINGS, ADJUSTED ALL RINSE VOLUMES AND ALIGNED SYRINGE BARRELS. TO VERIFY THE ANALYZER OPERATION, HE RAN CALIBRATION, QUALITY CONTROL AND PRECISION TESTING.