ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

Description of Event or Problem

THE CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) IN REGARDS TO RECEIVING HIGHER THAN EXPECTED FRT4 RESULT ABOVE THE NORMAL REFERENCE RANGE FOR ONE PATIENT GENERATE BY THE ACCESS 2 IMMUNOASSAY ANALYZER. THE ERRONEOUS RESULT WAS SUBMITTED OUT OF THE LABORATORY AND WAS QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS RETESTED ON AN ALTERNATE METHODOLOGY AND LOWER RESULT WITHIN THE NORMAL REFERENCE RANGE WAS OBTAINED. PATIENT TREATMENT WAS NOT IMPACTED DUE TO THIS EVENT. QC CHARTS, BOTH LEVELS OF FRT4 QC RESULTS HAVE BEEN WITHIN THE CUSTOMER ESTABLISHED RANGES. ON (B)(6) 2011, THE CUSTOMER PERFORMED ROUTINE SYSTEM CHECK, WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. ON THE (B)(6) 2011 A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND DRIED WASH BUFFER BUILD-UP AROUND THE WASH CAROUSEL. THE FSE PERFORMED A PREVENTIVE MAINTENANCE ON THE INSTRUMENT. THE FSE INSTALLED NEW ASPIRATE PROBES, A NEW SUBSTRATE PROBE, A NEW WASH TOWER INSERT, A NEW MIXER BELT, NEW MIXER PULLEYS, NEW PERI-PUMP TUBING AND NEW REACTION VESSELS HOLDERS. THE FSE PERFORMED A ROUTINE SYSTEM CHECK AND ASSAY QC AND DID NOT REPORT ANY ISSUES. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

Additional Manufacturer Narrative

THE SAMPLES WERE COLLECTED IN FRT4 SAMPLES IN SERUM TUBES WITH A GEL SEPARATOR AND CENTRIFUGED FIFTEEN MINUTES AT 3000 RPM. THE CUSTOMER STATED TO CUSTOMER TECHNICAL SUPPORT (CTS) THAT THE SAMPLES ARE ANALYZED FROM THE PRIMARY TUBES.