BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 1811802 · Received August 23, 2010

    Report

    Report Number
    1061932-2010-00124
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 23, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER USES 2.6ML, 65MM X 13MM SARSEDT BLOOD TUBES FOR SAMPLE COLLECTION, WHICH IS AN APPROVED TUBE ON THE HEMATOLOGY TUBE LIST FOR THE DXH 800 INSTRUMENT. THE TUBE MANUFACTURER CONFIRMED THAT THERE ARE NO ISSUES WITH THE MANUFACTURING PROCESS OF THE COLLECTION TUBES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND PERFORMED A FULL SAMPLE ASPIRATION MODULE (SAM) ALIGNMENT ON EACH SYSTEM AND NO ISSUES WERE FOUND. ALIGNMENT OF THE PIERCING ZONE WAS GOOD. A CLEAR ROOT CAUSE FOR THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THAT THE SAMPLE PROBE ON THE UNICEL DXH 800 COULTER INSTRUMENTS, UPON ASPIRATION OF THE SAMPLE TUBE, PUSHED IN THE RUBBER MEMBRANE OF A SARSEDT COLLECTION TUBE AND CAUSED BLOOD TO SPILL OUT INTO THE SYSTEM. NO PATIENT RESULTS WERE GENERATED AS THE EVENT OCCURRED DURING VALIDATION AND ACCEPTANCE TESTING OF THE DXH 800 INSTRUMENTS. THE OPERATOR WAS WEARING PPE AND THERE WAS NO BLOOD EXPOSURE TO EYES, MOUTH OR OPEN LESIONS; NO ONE SOUGHT MEDICAL ATTENTION. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. DXH 800

    Patients

    Seq Age Sex Outcome Treatment
    1