BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER PREP PLUS 2 WORKSTATION

    MDR report key: 2180981 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00696
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    March 16, 2009
    Report Date
    September 8, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQW
    PMA / PMN Number
    CLASS I EXEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN (B)(6) 2008 AND (B)(6), 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. A FIELD SERVICE ENGINEER (FSE) PRESENT AT THE SITE AT THE TIME OF THE INCIDENT ON (B)(6) 2009 IDENTIFIED THE MALFUNCTION AS AN ERROR WITH THE HOMING SENSOR ON THE PIPETTE. THE FSE WAS ABLE TO REPAIR THE SENSOR AT THAT VISIT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A DEMONSTRATION TEST OF THE PREP PLUS 2 INSTRUMENT, THE SAMPLE PROBE BECAME STUCK IN TUBES CONTAINING (B)(6) BLOOD AND BLOOD WAS SPLATTERED ALL OVER THE INSTRUMENT. THE INSTRUMENT HAD BEEN LEFT RUNNING DURING THE DEMO TEST AND NO ONE WAS AROUND THE INSTRUMENT WHEN THE INCIDENT OCCURRED. THERE WERE NO REPORTED INSTANCES OF EXPOSURE TO POTENTIALLY INFECTIOUS MATERIAL. NO PT RESULTS WERE GENERATED FROM THE SAMPLES DURING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER PREP PLUS 2 WORKSTATION JQW BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK