BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2033841 · Received March 30, 2011

    Report

    Report Number
    2050012-2011-00842
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPLACED THE WASH PROBES BUT THAT DID NOT RESOLVE THE ISSUE. THE CUSTOMER REMOVED REACTION CAROUSEL WHEEL AND FOUND BLUISH GREEN FLUID HAD LEAKED OUT. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND 3 WASH STATION PROBES WITH BROKEN CUVETTE GLASS STUCK IN BOTTOM ASPIRATION PORT. FSE REPLACED THE PROBES AND PERFORMED ALIGNMENTS. FSE ALSO REPLACED 8 DIRTY CUVETTES AND INSPECTED ALL OTHERS. FSE RAN QC AND VERIFIED INSTRUMENT OPERATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE CUVETTES STARTED FAILING AND ONE OF THE WASH PROBES WAS SPRUNG. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1