BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2232162 · Received September 2, 2011

    Report

    Report Number
    2050012-2011-04760
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT A WASH COLLAR VACUUM/WASTE VALVE WAS REMOVED OFF OF ANOTHER INSTRUMENT AND INSTALLED IT ON THE LEAKING INSTRUMENT WHICH RESOLVED THE ISSUE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THE MODULAR CHEMISTRY (MC) SAMPLE PROBE WAS LEAKING FLUID IN THE UNICEL DXC 800 SYNCHRON CHEMISTRY ANALYZER. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1