BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750

    MDR report key: 2041873 · Received April 6, 2011

    Report

    Report Number
    1061932-2011-00225
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THEY THINK THIS OCCURRED BECAUSE THE TUBE LABEL WAS CAUGHT ON THE STRIPPER PLATE CAUSING THE CAP TO BE REMOVED. THE SAMPLE WAS A SMALL LAVENDER TUBE WITH CONVENTIONAL CAP. THE SPILL WAS CLEANED UP ACCORDING TO HOSPITAL POLICY. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (GLOVES AND LAB COAT). PER SERVICE REQUEST, THERE WAS NO REPORT OF A STRIPPER PLATE PROBLEM. ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THAT A SMALL CONVENTIONAL CAPPED TUBE OPENED WHILE BEING RUN ON COULTER LH 750 ANALYZER. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH 750

    Patients

    Seq Age Sex Outcome Treatment
    1