BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 3102248 · Received May 9, 2013

    Report

    Report Number
    2122870-2013-00441
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) CLEANED THE WASH WHEEL AND NOTED A SIGNIFICANT AMOUNT OF WASH BUFFER SALTS PRESENT. THE FSE REMOVED THE LUMINOMETER AND CLEANED THE LENS. THE FSE REPLACED THE DUCK-BILL VALVE AND PRIMED THE INSTRUMENT THEN NOTICED ASPIRATE PROBE #2 WAS NOT PROPERLY ASPIRATING FROM THE REACTION VESSEL (RV). THE FSE REPLACED THE ASPIRATE PROBE #2 AND THE ASSOCIATED PERISTALTIC PUMP TUBING. THE FSE VERIFIED INSTRUMENT PERFORMANCE AND NO ISSUES WERE NOTED. A ROUTINE SYSTEM CHECK WAS PERFORMED WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE HYBRITECH PROSTATE-SPECIFIC ANTIGEN (PSA) ASSAY WAS RECALIBRATED AND QUALITY CONTROL (QC) WAS PERFORMED; NO ISSUES WERE NOTED. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS PROSTATE-SPECIFIC ANTIGEN (PSA) RESULTS, FOR THREE PATIENTS, INVOLVING THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM USED IN CONJUNCTION WITH THE ACCESS HYBRITECH PSA ASSAY AND CALIBRATOR. SUBSEQUENT TESTING OF THE PATIENTS' SAMPLES, AT A REFERENCE LABORATORY, THROUGH AN ALTERNATE METHODOLOGY, PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE FOR ALL THREE PATIENTS. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THERE WAS NO REPORT OF PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. ONE PATIENT'S RESULT WAS AMENDED DUE TO THE DIFFERENCE IN RESULTS OBTAINED BETWEEN THE UNICEL DXI 600 SYSTEM AND THE ALTERNATE METHODOLOGY. QUALITY CONTROL (QC) WAS WITHIN SPECIFICATION AT THE TIME OF THE EVENT. THE PATIENT SAMPLES WERE COLLECTED OFFSITE IN 12X75 MM BECTON DICKINSON (BD) SERUM SEPARATION TUBES (SST), WERE FULL COLLECTIONS, AND NORMAL IN APPEARANCE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204228 UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1