BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BECKMAN COULTER LAB AUTOMATION SYSTEM

    MDR report key: 2144909 · Received June 30, 2011

    Report

    Report Number
    2050012-2011-02574
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BECKMAN COULTER BIOMEDICAL GMBH
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE REQUIRED SECOND PAIR OF GLOVES WAS NOT WORN DURING MAINTENANCE. THE OMITTED COTTON GLOVES ARE NOT FOR PROTECTION PURPOSE BUT FOR AVOIDING TRACES OF GREASE OR FAT ON THE MIRROR. AS THE FIELD SERVICE TECHNICIAN WAS NOT WEARING THE REQUIRED PPE, USE ERROR IS A CONTRIBUTING CAUSE TO THIS EVENT.

    Description of Event or Problem · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER REPORTED THAT DURING ROUTINE SERVICE AND CLEANING OF THE BECKMAN COULTER LAB AUTOMATION SYSTEM, HE GRAZED HIS HAND AGAINST THE EDGE OF ONE OF THE MIRRORS USED IN THE TUBE INSPECTION UNIT (TIU). THIS AREA IS ONLY ACCESSIBLE TO MAINTENANCE PERSONNEL AND THE MAINTENANCE INVOLVED IN THIS EVENT IS ONLY PERFORMED BY BECKMAN COULTER FIELD SERVICE ENGINEERS. THE MIRROR THAT CAUSED THE GRAZE IS CHAMFERED BY SPECIFICATIONS, BUT IT IS NOT FRAMED OR ROUNDED. CONTACT WITH THE MIRROR RESULTED IN A CUT TO HIS FINGER WHICH BLED SLIGHTLY. THE MIRROR INVOLVED HAD BEEN DISINFECTED WITH ETHANOL JUST PRIOR TO THE INJURY ASSOCIATED WITH THIS REPORT. THE SERVICE ENGINEER WAS WEARING A LAB COAT AND RUBBER GLOVES AT THE TIME OF THE INCIDENT, HOWEVER, WAS NOT WEARING THE LINT-FREE COTTON GLOVES REQUIRED IN THE USER'S GUIDE. THE FSE WENT TO THE MEDICAL DEPARTMENT AND A BLOOD SAMPLE WAS TAKEN AS A BASELINE FOR IN-VITRO DIAGNOSTIC TESTING FOR BLOOD-BORNE DISEASES. BASELINE TESTING SHOWED NO (B)(4), (B)(4) OR (B)(4). THE FSE RECEIVED A PROACTIVE TETANUS INOCULATION, BUT NO OTHER PROPHYLAXIS WAS ADMINISTERED. THIS EVENT OCCURRED AT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER LAB AUTOMATION SYSTEM LAB AUTOMATION JQP BECKMAN COULTER BIOMEDICAL GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention