BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2084921 · Received May 11, 2011

    Report

    Report Number
    2122870-2011-01283
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011. THE FSE DID NOT FOUND ANY LEAKS OR LIQUID INSIDE OF THE ANALYZER. THE FSE SUSPECTED THAT CONDENSATION HAD FORMED AND LEAKED OUT OF REAGENT CAROUSEL. THE FSE CLEANED OUT THE CONDENSATION FROM THE REAGENT CARROUSEL. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) HOTLINE REPORTING A LEAK ORIGINATING FROM THE RIGHT SIDE OF THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM NEAR THE ON/OFF SWITCH. HOTLINE ADVISED THE CUSTOMER THEY SHOULD NOT USE THE INSTRUMENT UNTIL ON SITE SERVICE FOR THAT INSTRUMENT HAD BEEN COMPLETED. THERE WAS NO REPORT OF INJURY TO THE USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1