COBAS 6000 CORE

Description of Event or Problem

THE CUSTOMER RECEIVED INTERMITTENT QUESTIONABLE RESULTS FOR MULTIPLE ASSAYS FOR APPROXIMATELY ONE WEEK. THE ASSAYS INVOLVED WERE ALANINE AMINOTRANSFERASE, ASPARTATE AMINOTRANSFERASE, BICARBONATE AND CALCIUM. THE ISSUE INVOLVED AN UNKNOWN NUMBER OF PATIENTS AND OCCURRED WHEN THE REAGENT PACKS WERE LOW (LESS THAN 30 TESTS). THE CUSTOMER PROVIDED RESULTS FOR EIGHT PATIENT SAMPLES. THE ALANINE AMINOTRANSFERASE WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (ALT) RESULTS FOR ONE SAMPLE WERE DISCREPANT. THE INITIAL ALT RESULT WAS 1 U/L AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED ON AN INTEGRA 400 AND RECOVERED 79 U/L. THIS RESULT WAS SENT OUTSIDE THE LABORATORY IN A CORRECTED REPORT. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE ALT REAGENT LOT NUMBER WAS 63220401. THE FIELD SERVICE REPRESENTATIVE DETERMINED A REAGENT SAMPLING ISSUE WAS THE CAUSE. HE CLEANED AND LUBRICATED THE X DRIVE ASSEMBLY FOR THE R2 PROBE. HE REINSTALLED THE R2 SYRINGE BARREL AND PERFORMED ALL PROBE ALIGNMENTS. ALL DIAGNOSTICS AND CUSTOMER'S CONTROLS WERE ACCEPTABLE.