BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2882877 · Received December 21, 2012

    Report

    Report Number
    2122870-2012-02007
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 20, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LTJ
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THE FITTINGS FOR THE DISPENSE PROBES WERE BROKEN AND REPLACED ALL THREE FITTINGS FOR THE DISPENSE PROBES. THE FSE PROACTIVELY REPLACED THE PERISTALTIC PUMP TUBING AND PERFORMED THERMAL HARDWARE MODIFICATION. SERVICE ACTIVITY PERFORMED WAS VERIFIED PER ESTABLISHED PROCEDURES. THE UNIT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS PROSTATE-SPECIFIC ANTIGEN (PSA) RESULTS, FOR SEVERAL PATIENTS, AND FAILED QUALITY CONTROL (QC) AND CALIBRATIONS INVOLVING THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER DISCONTINUED ANALYZING PATIENT SAMPLES AFTER QC AND CALIBRATIONS FAILED. THE ERRONEOUS RESULTS DID NOT CORRELATE WITH THE PATIENTS' CLINICAL HISTORIES. THE CUSTOMER COULD NOT CONFIRM THE NUMBER OF PATIENTS INVOLVED OR THE NUMBER OF ERRONEOUS RESULTS. THE ERRONEOUS RESULTS WERE NOT RELEASED FROM THE LABORATORY. THERE WAS NO PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER PERFORMED PROBE MAINTENANCE ON (B)(6) 2012 AND REQUESTED SERVICE. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1