BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2462639 · Received February 21, 2012

    Report

    Report Number
    1061932-2012-00571
    Event Type
    Malfunction
    Date Received
    February 21, 2012
    Date of Event
    January 25, 2012
    Report Date
    January 26, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER WENT ON-SITE AND CHECKED (SAMPLE ASPIRATION MODULE) SAM ALIGNMENTS, BUT INDICATED THAT OCCASIONALLY CAPS ARE STILL PUSHED THROUGH AFTER PERFORMING THE ADJUSTMENT. FSE CHANGED THE MANUAL STATION HOLDER AND TESTED WITH SARSTEDT TUBES WITH NO ISSUES. THE COMPRESSOR WAS ALSO REPLACED TO ADDRESS THE VIBRATION ISSUES. THE CAUSE FOR THE TUBES BEING PUSHED IN IS UNKNOWN. THERE IS AN ONGOING INVESTIGATION AT BEC FOR SIMILAR REPORTS OF SARSTEDT TUBE TOPS BEING PUSHED IN DURING SPECIMEN PROCESSING ON THE DXH800 SYSTEM. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THE TOPS OF THE SARSTEDT SPECIMEN TUBES WERE BEING PUSHED IN RATHER THAN BEING PIERCED DURING SPECIMEN PROCESSING, RESULTING IN BLOOD SPILLING FROM THE TUBE ON THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE CUSTOMER ALSO OBSERVED THAT THE SAMPLE PROBE WAS MISALIGNED WHEN SAMPLING IN THE OPEN TUBE MODE AND THE MANUAL TUBE HOLDER WAS LOOSE. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE). NO INJURY OR EXPOSURE WAS REPORTED. THERE WAS NO AFFECT TO PATIENT SAMPLES WITH REGARD TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. DXH 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1