ADVIA 120

Description of Event or Problem

IN 2005 A LAB MANAGER AT A MEDICAL CENTER REPORTED THAT THEIR LABORATORY HAD SENT OUT A DISCREPANT RESULT FOR A PATIENT'S HEMATOCRIT LEVEL THAT LED TO THE PATIENT BEING TRANSFUSED WITH ONE UNIT OF BLOOD. THE PATIENT WAS UNDERGOING JOINT REPLACEMENT SURGERY AND WAS BEING MONITORED FOR BLOOD LOSS. THE MEDICAL CENTER CLAIMS THAT IN 2005 A HEMATOCRIT TEST WAS RUN ON THE ADVIA 120 INSTRUMENT, THE INITIAL RESULT FOR HEMATOCRIT OF 24.4 WAS REPORTED AND BASED ON THIS RESULT THE PATIENT RECEIVED A BLOOD TRANSFUSION. A SUBSEQUENT TEST OF THE SAME SAMPLE GAVE A RESULT OF 27.1%. A BAYER FIELD SERVICE ENGINEER WAS DISPATCHED TO INSPECT THE INSTRUMENT. UPON INSPECTION THE ENGINEER NOTED THAT THE SAMPLE LINE UNDER THE NEEDLE BASE WAS LOOSE. THIS CAUSES AIR TO BE ASPIRATED INTO THE LINE, DILUTING THE SAMPLE PRODUCING ABERRANT RESULTS. THE ENGINEER TIGHTENED THE LINE AND THE INSTRUMENT PERFORMED AS INTENDED AFTER THAT.