BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1896228 · Received November 10, 2010

    Report

    Report Number
    2122870-2010-00727
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 13, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COLLECTS BHCG SAMPLES IN 13X75MM LITHIUM HEPARIN PLASMA TUBES. ALL THREE LEVELS OF BHCG QC HAVE BEEN WITHIN THE CUSTOMER'S ESTABLISHED RANGES. A ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(6) 2010 WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE CUSTOMER PERFORMED A PRECISION TEST USING THE PATIENT'S SAMPLE AND EXPERIENCED IMPRECISION ACROSS ALL THREE PIPETTORS TESTED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE INSPECTED THE INSTRUMENT AND FOUND THE ROTOR AD VALVE ON PRECISION PUMP #3 WAS RUSTY. THE FSE ALSO NOTED THAT THE UPPER SPRING ON PRECISION PUMP #3 WAS OLD AND NEEDED TO BE REPLACED. THE FSE REPLACED ALL AFFECTED PARTS AND VERIFIED REAGENT PROBE ALIGNMENTS, PIPETTOR MATCHING, LOW VOLUME PIPETTOR MATCHING AND CALIBRATED PRESSURE SENSORS; NO ISSUES WERE NOTED. ALTHOUGH SOME HARDWARE ISSUES WERE ADDRESSED, A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING ERRATIC TOTAL BHCG (TBHCG) RESULTS WITHIN DIFFERENT GESTATIONAL CATEGORIES GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. SUBSEQUENT TESTING ON THIS AND ON AN ALTERNATE INSTRUMENT PRODUCED RESULTS WITHIN A LOWER GESTATIONAL CATEGORY. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER DHA BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1