BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 660I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3771920 · Received April 25, 2014

    Report

    Report Number
    2050012-2014-00213
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO ASSESS THE INSTRUMENT. THE FSE DETERMINED THAT A WIRE ON THE REAGENT PROBE LEVEL SENSE ASSEMBLY WAS BROKEN. THE FSE REPLACED THE WIRE AND LOADED SEVERAL REAGENT CARTRIDGES WITHOUT ERROR. NO FURTHER LEAKS WERE OBSERVED AND NO FURTHER LEVEL SENSE ERROR MESSAGES WERE GENERATED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING REAGENT PROBE LEVEL SENSE ERRORS ON A UNICEL DXC 660I SYNCHRON ACCESS CLINICAL SYSTEM WHEN LOADING REAGENT CARTRIDGES. THE CUSTOMER ALSO REPORTED LIQUID ON THE DRIP TRAY BENEATH THE REAGENT CARTRIDGE PROBE. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE LEAK. THERE WAS NO REPORT OF DIRECT CONTACT WITH LEAK OR OF INJURY RELATED TO THE LEAK. THERE WERE NO ERRONEOUS RESULTS GENERATED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251206 UNICEL® DXC 660I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1