BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH500 HEMATOLOGY ANALYZER

    MDR report key: 2361888 · Received December 7, 2011

    Report

    Report Number
    1061932-2011-02561
    Event Type
    Malfunction
    Date Received
    December 7, 2011
    Date of Event
    November 9, 2011
    Report Date
    November 9, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INFORMATION PROVIDED BY CUSTOMER, OPERATOR DID NOT HEAR THE AUDIBLE WARNING BEEP ALERTING HIM TO REMOVE THE SPECIMEN TUBE FROM THE ASPIRATION PROBE BEFORE THE PROBE RETRACTED. CUSTOMER COULD NOT CONFIRM WHETHER OR NOT OPERATOR HAS A HEARING IMPAIRMENT. ADDITIONALLY, BOTH THE HOTLINE AND SERVICE VERIFIED THAT THE AUDIBLE WARNING BEEP FOR THE MANUAL MODE ON THE INSTRUMENT WAS FUNCTIONING PER ESTABLISHED INSTRUMENT SPECIFICATIONS. THEREFORE, THE ROOT CAUSE IS RELATED TO A USER ERROR, AS NO MALFUNCTION OF THE INSTRUMENT WAS IDENTIFIED. PLEASE NOTE THAT, PER LABELING, BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. ((B)(4).)

    Description of Event or Problem · 1

    CUSTOMER CALLED ON (B)(6) 2011 TO REPORT THAT WHILE PROCESSING OF A SPECIMEN TUBE IN THE MANUAL (SECONDARY) MODE, THE TUBE FELL FROM THE OPERATOR'S HAND, WITHOUT BREAKING, AND THE BLOOD SAMPLE CONTENTS SPLASHED ONTO OPERATOR. OPERATOR WAS NOT WEARING GLOVES OR EYE PROTECTION, BUT A SHORT SLEEVED LAB COAT AS PERSONAL PROTECTIVE EQUIPMENT (PPE). AS A CONSEQUENCE, THE OPERATOR'S HAND AND FOREARM CAME IN CONTACT WITH THE BLOOD. OPERATOR WENT TO THE MEDICAL CENTER OF THE FACILITY, PER THE FACILITY'S EXPOSURE PLAN, TO OBTAIN SEROLOGICAL BASELINE TESTING FOR THE WORK RELATED EXPOSURE. CUSTOMER CONFIRMED THAT THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES (EYES, MOUTH OR NOSE) OR OPEN WOUNDS, AND THAT THERE WAS NO DEATH, INJURY, OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. LH500

    Patients

    Seq Age Sex Outcome Treatment
    1