BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH SLIDEMAKER STAINER

    MDR report key: 2544072 · Received April 20, 2012

    Report

    Report Number
    1061932-2012-01262
    Event Type
    Malfunction
    Date Received
    April 20, 2012
    Date of Event
    March 28, 2012
    Report Date
    March 28, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKJ
    PMA / PMN Number
    CLASS I EXEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT BATH 1 OF THE UNICEL DXH SLIDEMAKER STAINER HAD OVERFLOWED WITH METHANOL INTO THE BATH TRAY. THE CUSTOMER INDICATED THAT THE BATH TRAY FILLED COMPLETELY AND ULTIMATELY OVERFLOWED INTO THE INSTRUMENT. APPROXIMATELY 10 ML WAS SPILLED INTO THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, LAB COAT AND EYE PROTECTION AND NO EXPOSURE OR INJURY WAS REPORTED. PATIENT RESULTS WERE NOT AFFECTED AND THERE WAS NO CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) STATED THAT THE BATH 1 SENSOR AND OVERFLOW SENSOR WERE COVERED WITH DEBRIS CAUSING THE DXH SLIDEMAKER STAINER TO OVERFLOW. FSE PROCEEDED TO REPLACE THE BATH 1 AND OVERFLOW SENSORS AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXH SLIDEMAKER STAINER SPINNER, SLIDE, AUTOMATED GKJ BECKMAN COULTER INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1