BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM (FULL SYSTEM)

    MDR report key: 2060509 · Received April 18, 2011

    Report

    Report Number
    2050012-2011-01184
    Date Received
    April 18, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ATTEMPTED TO RUN HOT WATER THROUGH MODULE BUT THIS DID NOT RESOLVE THE ISSUE. A BCI FIELD SERVICE ENGINEER (FSE) FOUND PHOSPHORUS CUP NOT DRAINING AND REPLACED WASTE VALVE ON CUP MODULE. THIS DID NOT RESOLVE THE ISSUE. FSE REPLACED THE ENTIRE PHOS MODULE TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO PHOSPHOROUS MODULE (PHOSM) NOT DRAINING WATER OR REAGENT PROPERLY. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM (FULL SYSTEM) DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER, JJE BECKMAN COULTER INC. DXC 880I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1