BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI® 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 3026487 · Received March 28, 2013

    Report

    Report Number
    2122870-2013-00321
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY LOW OR NEGATIVE PATIENT SAMPLE RESULTS INVOLVING THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER SUPPLIED ARCHIVED DATA WHICH INDICATED NEGATIVE RESULTS OF APPROXIMATELY ZERO ON SEVERAL ASSAYS INCLUDING GI MONITOR (FOR QUANTITATIVE DETERMINATION OF CA 19-9 ANTIGEN), AFP (ALPHA-FETOPROTEIN), AND CEA (CARCINOEMBRYONIC ANTIGEN). THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. IT IS UNKNOWN OF EXACTLY WHICH ASSAYS AND WHICH PATIENT RESULTS IN THE SUPPLIED ARCHIVED DATA WERE AFFECTED BY THIS EVENT. ACTUAL PATIENT RESULT DATA FOR THE PATIENTS IN QUESTION HAS NOT BEEN SUPPLIED BY THE CUSTOMER. THE CUSTOMER STATED THAT QUALITY CONTROL (QC) RESULTS WERE WITHIN SPECIFICATIONS BEFORE AND AFTER THE EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPORTED THAT THE CUSTOMER ALLEGED TWENTY-NINE (29) ERRONEOUSLY LOW PATIENT RESULTS IN CONNECTION TO THIS EVENT. THE FSE STATED THAT THE CUSTOMER WAS UNABLE TO OBTAIN REPEAT RESULTS FOR THE 29 PATIENT RESULTS. THE FSE NOTED A PINHOLE IN TUBING OF PIPETTE #1 AND PROCEEDED TO REPLACE THE TUBING. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. THE FSE INDICATED THAT A PINHOLE IN PIPETTE #1 WAS THE CAUSE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128482 UNICEL DXI® 800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1