COBAS 6000 C501 MODULE

Additional Manufacturer Narrative

IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

Description of Event or Problem

THE USER ALLEGED 5 PATIENT SAMPLES HAD ERRATIC RECOVERY FOR TOTAL PROTEIN (TP) AND ALBUMIN (ALB). THE USER STATED ALL OTHER TESTS RUNNING FINE. RESULTS FOR 3 PATIENT SAMPLES WERE PROVIDED WHICH WERE DISCREPANT FOR TP AND OR ALB. SAMPLE 1, INITIAL TP GAVE 0.0; REPEAT GAVE 7.0 G/DL. SAMPLE 2, FEMALE, (B) (6), INITIAL TP GAVE 2.0 G/DL. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE DOCTOR QUESTIONED THE RESULT AND REQUESTED THE SAMPLE BE REPEATED. REPEAT TP GAVE 7.6 G/DL. USER SAID THE PATIENT WAS NOT TREATED BASED ON THE INITIAL RESULT REPORTED. SAMPLE 3, FEMALE, (B) (6), INITIAL ALBUMIN GAVE - 0.2; REPEAT GAVE 4.1 G/DL. ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY FOR SAMPLE 2 ONLY. THE PATIENTS WERE NOT ADVERSELY AFFECTED. TP REAGENT LOT NUMBER - 61868401. ALB REAGENT LOT NUMBER - 61870001 THE FIELD SERVICE REPRESENTATIVE DETERMINED SPECIMEN PREPARATION BY CUSTOMER, LIKELY A CLOT, CAUSED THE DISCREPANT RESULTS. IN ADDITION HE NOTED A SAMPLE CLOT INSTRUMENT ALARM WAS GENERATED FOR THE SPECIMEN IN QUESTIONED. HE VERIFIED FLUIDICS AND MECHANICAL ALIGNMENTS WERE GOOD WITH NO CHANGE. UPON HIS ARRIVAL, CUSTOMER HAD PERFORMED A PROBE WASH FOR THE SAMPLE CLOT ERROR AND RAN CONTROLS WHICH RECOVERED WITHIN RANGE. CUSTOMER SUCCESSFULLY RAN CALIBRATION AND CONTROLS. HE RAN A PRECISION STUDY TO VERIFY ANALYZER WAS PERFORMING WITHIN SPECIFICATION. NO FURTHER PROBLEMS HAVE BEEN REPORTED.