BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2221110 · Received August 23, 2011

    Report

    Report Number
    2122870-2011-03093
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    May 12, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) CORRECTED INSTRUMENT ALIGNMENTS AND REPLACED ASPIRATE PROBES AND ASPIRATE PROBE TUBING. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES ONCE HARDWARE REPAIRS WERE COMPLETE. THE INSTRUMENT WAS RETURNED INTO SERVICE ONCE INSTRUMENT PERFORMANCE WAS CONFIRMED. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT MULTIPLE, HIGHER THAN EXPECTED FREE THYROXINE (FT4) RESULTS WERE GENERATED FROM AN ACCESS 2 IMMUNOASSAY SYSTEM FOR AN UNDISCLOSED NUMBER OF PATIENTS OVER AN UNDEFINED PERIOD OF TIME. THE CUSTOMER INDICATED THAT SOME SLIGHTLY ELEVATED FREE T4 RESULTS, ABOVE THE NORMAL REFERENCE RANGE, HAD BEEN GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR SOME ''NON-THYROID'' PATIENTS. THE ACTUAL INITIAL RESULTS HAD NOT BEEN PROVIDED BY THE CUSTOMER. THESE RESULTS HAD BEEN REPORTED OUTSIDE OF THE LABORATORY AND WERE QUESTIONED BY PHYSICIANS. SOME OF THE INITIAL RESULTS WERE REPEATED, HOWEVER, IT IS UNKNOWN AS TO WHETHER THERE WERE ANY ISSUES WITH RESULT REPRODUCIBILITY. THE REPEAT RESULTS HAD NOT BEEN SUPPLIED BY THE CUSTOMER. THE CUSTOMER WAS NOT ABLE TO DEFINE THE ACTUAL DATES OF OCCURRENCE, OR ACTUAL FT4 RESULTS OBTAINED. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER HAS NOT PERFORMED ANY PATIENT POPULATION REFERENCE RANGE STUDIES TO ESTABLISH A PEER POPULATION REFERENCE RANGE. THE SAMPLES WERE ALL TIGER TOP, GEL-SEPARATOR TUBES AND WERE RUN FROM THE PRIMARY TUBE. THEIR APPEARANCE WAS NORMAL WITHOUT ANY VISIBLE ABNORMALITIES. ALTHOUGH FT4 QUALITY CONTROL RESULTS WERE RECOVERING WITHIN THE CUSTOMER'S ESTABLISHED SPECIFICATION RANGE, THE CUSTOMER INDICATED THAT THEY WERE EXPERIENCING FT4 SYSTEM CHECK FAILURES. DATA PROVIDED BY THE CUSTOMER INDICATED FAILED CALIBRATIONS FOR MULTIPLE ASSAYS (TOTAL T3, TESTOSTERONE, VITAMIN B12, THYROPEROXIDASE ANTIBODY, AND FRT4) WHICH FAILED DUE TO A NUMBER OF CAUSES INCLUDING SYSTEM FLAGS, HIGH IMPRECISION AND CALIBRATOR CONSISTENCY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS FREE T4 REAGENT