UNICEL¿ DXL800 ACCESS® IMMUNOASSAY SYSTEM

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER (FSE) PERFORMED A SYSTEM CHECK. THE UNWASHED AND SUBSTRATE PORTIONS OF THE ASSESSMENT FAILED TO MEET SPECIFICATION. THE FSE REPLACED A NUMBER OF PARTS WITHOUT SUCCESS. ULTIMATELY HE REPLACED THE SUBSTRATE PUMP. SUBSEQUENT VERIFICATION TESTING, INCLUDING AN EXECUTED SYSTEM CHECK, MET ESTABLISHED SPECIFICATION. ALTHOUGH REPAIRS WERE MADE THROUGH ON-SITE SERVICE, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN IDENTIFIED TO DATE. THE FOLLOWING ARE MDRS ASSOCIATED WITH THIS EVENT: 2122870-2011-01532, 2122870-2011-01543. THIS IS REPORT ONE OF TWO.

Description of Event or Problem

THE CUSTOMER REPORTED THAT ON (B)(6) 2011 AND (B)(6) 2011 MULTIPLE, IMPRECISE UNCONJUGATED ESTRIOL (UE3) RESULTS WERE GENERATED FROM A UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM. THE EXACT NUMBER OF INVOLVED RESULTS IN UNKNOWN. THIS REPORT REPRESENTS THE EVENT DATE OF (B)(6) 2011. THE INITIAL, QUESTIONABLE RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE HAS BEEN NO INFORMATION PROVIDED WHICH INDICATES THE RESULTS LED TO A DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT. REPEAT RESULTS WERE GENERATED BY THE LABORATORY. A COMPARISON OF REPEAT RESULTS IN RELATION TO INITIAL RESULTS VALUES WAS PERFORMED BY THE CUSTOMER'S GENETIC LABORATORY. IT WAS DETERMINED THAT THE AMOUNT OF DISCREPANCY WAS NOT SIGNIFICANT ENOUGH, IN ALL CASES BUT ONE, TO CHANGE CLINICAL INTERPRETATION OF THE RESULTS. ONE AMENDED REPORT WAS REPORTED. THE CUSTOMER WAS NOT ABLE TO PROVIDE INITIAL OR REPEAT RESULT DATA ASSOCIATED WITH THE AMENDED REPORT. DATA SUPPLIED BY THE CUSTOMER WAS ASSESSED. THE ASSESSMENT INDICATED THAT THERE WERE NO REPEAT TESTS WITH A DIFFERENCE OF 10% OR GREATER WHEN COMPARED TO INITIAL RESULTS. HOWEVER THERE WERE SEVERAL REPEAT RESULTS THAT WERE IMPOSSIBLE TO CORRELATE TO INITIAL RESULTS BECAUSE OF CUSTOMER MANUALLY PROGRAMMED SAMPLE IDENTIFICATION ISSUES. DATA SUPPLIED BY THE CUSTOMER ALSO INDICATED THAT QUALITY CONTROL RESULTS (QC) WERE OUTSIDE THE CUSTOMER'S ESTABLISHED RANGES FOR LEVELS 1 & 3 PRIOR TO EVENT. UE3 CALIBRATION ON (B)(6) 2011 MET SPECIFICATION. THE CUSTOMER NOTED NO ISSUES WITH OTHER ASSAYS. THE CUSTOMER INDICATED THAT THE TOTAL ALLOWABLE ERROR (TEA) EMPLOYED FOR UE3 PRECISION ASSESSMENTS DURING THIS EVENT WAS 15%. BECKMAN COULTER INC. CLAIMS AN ACHIEVABLE TEA FOR UE3 OF 30%.