ACCESS 2 IMMUNOASSAY SYSTEM

Description of Event or Problem

A CUSTOMER CONTACTED BECKMAN COULTER REGARDING FALSE NEGATIVE TOTAL BHCG (TBHCG) TEST RESULT FROM A SINGLE PT THAT WAS GENERATED BY THE ACCESS 2 INSTRUMENT. THE CUSTOMER INDICATED THAT THE TBHCG RESULT WAS 1.25MIU/ML. THE RESULT WAS REPORTED OUT OF THE LAB. THE CUSTOMER INDICATED THAT A URINE SAMPLE WAS COLLECTED FROM THE PT AND TESTED FOR TBHCG BY QUALITATIVE METHOD; THE RESULT WAS POSITIVE. THE CUSTOMER INDICATED THAT A NEW BLOOD SAMPLE (#2) WAS COLLECTED FROM THE PT AND TESTED (NEAT) FOR TBHCG; THE RESULT WAS ">1000.00MIU/ML". THE CUSTOMER INDICATED THAT THE SAMPLE #2 WAS RE-TESTED (DILUTION) FOR TBHCG; THE RESULT WAS 23,016.20MIU/ML. THE CUSTOMER THEN REPEATED THE PT'S INITIAL SAMPLE FOR TBHCG; THE RESULT WAS 22,386MIU/ML. IN ADDITION, THE CUSTOMER INDICATED THAT THE PT STATED TO THE CUSTOMER THAT THIS TEST PREVIOUSLY RAN AT ANOTHER FACILITY WAS 13,000 (METHOD, UNITS AND DATE WERE NOT SUPPLIED). THE CUSTOMER INDICATED THAT THERE WAS NO CHANGE IN PT TREATMENT THAT CAN BE ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.