BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2110830 · Received June 1, 2011

    Report

    Report Number
    2050012-2011-01961
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND NOTICED LIQUID AROUND REACTION WHEEL BUT DID NOT NOTICE ANY PROBE LEAKING. FSE REPLACED LEVEL SENSE BEAD, REINSTALLED PROBE AND PERFORMED ALIGNMENTS. CUSTOMER RAN QC AND NOTICED A SLIGHT DRIP AT REAGENT PROBE HOME LOCATION. FSE REPLACED COLLAR WASH VACUUM VALVE AND VERIFIED REPAIR PER ESTABLISHED PROCEDURES AND NO FURTHER LEAKS WERE OBSERVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING A REAGENT PROBE WAS LEAKING FLUID ONTO COVER OF THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. NO FUMES WERE PRODUCED, CUSTOMER WAS NOT HARMED AND DID NOT NEED MEDICAL TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1