BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 3771787 · Received April 24, 2014

    Report

    Report Number
    2122870-2014-00299
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 31, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    LTJ
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) PERFORMED HIGH SENSITIVITY (HS) SYSTEM CHECK AND IT FAILED FOR PIPETTOR #4 WITH LEVEL SENSE ISSUE. THE FSE VALIDATED THE SYSTEM WITH PIPETTOR #4 DISABLED. THE FSE PERFORMED LEVEL SENSE TEST FOR THE SAMPLE AND REAGENT PIPETTORS. THE LEVEL SENSE TEST FOR SAMPLE PIPETTOR WAS ACCEPTABLE BUT FAILED THE TEST FOR REAGENT PIPETTORS #2 AND #4. THE FSE REPLACED THE PROBE TIPS AND CORRECTED ALIGNMENTS AND ULTRASONICS SETTINGS; THE FSE NOTED PIPETTOR #2 PASSED BUT #4 STILL FAILED. THE FSE REPLACED THE TRANSDUCER AND REAGENT PIPETTOR TUBING ON REAGENT PIPETTOR #4. THE FSE VERIFIED ALIGNMENTS AND ULTRASONICS SETTINGS, AND CALIBRATED THE PRESSURE SENSOR. THE FSE PERFORMED DAILY CLEAN AND NOTED SYSTEM CHECK PASSED. THE FSE ALSO PERFORMED A PASSING CARRYOVER TEST AND A 15-REPETITION PRECISION TEST FOR EACH REAGENT PIPETTOR. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, SYSTEM HARDWARE, ASSOCIATED WITH THE ULTRASONIC TRANSDUCER, IS THE LIKELY CAUSE OF THE EVENT. BECKMAN COULTER CONTINUES TO TRACK AND TREND ANY INCIDENT RELATED TO THIS ISSUE. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2014-00300.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY LOW PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT, FOR ONE PATIENT, INVOLVING THE UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM. AN INITIAL RESULT OF 0.01 NG/ML WAS OBTAINED AND QUESTIONED BY THE LABORATORY. THE CUSTOMER REANALYZED THE SAMPLE, ON THE SAME INSTRUMENT, AND OBTAINED A HIGHER RESULT OF 46.83 NG/ML. THE ERRONEOUS RESULT WAS NOT RELEASED FROM THE LABORATORY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. QUALITY CONTROL (QC) IS PERFORMED ONCE DAILY, AND NO QC ISSUES WERE NOTED. THE PATIENT'S SAMPLE WAS COLLECTED IN 13X100 MM BECTON DICKINSON (BD) SERUM TUBE. NO SAMPLE INTEGRITY ISSUES WERE NOTED. ALL INITIAL SAMPLE TESTING IS PERFORMED FROM THE AUTOMATION LINE (CONNECTED TO THE INSTRUMENT). THE SAMPLE WAS STORED AT ROOM TEMPERATURE PRIOR TO ANALYSIS. THE CUSTOMER REQUESTED SERVICE, AND A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250179 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE LTJ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1