BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 14596064 · Received June 3, 2022

    Report

    Report Number
    1061932-2022-00034
    Event Type
    Injury
    Date Received
    June 3, 2022
    Date of Event
    May 14, 2022
    Report Date
    June 3, 2022
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    UDI-DI
    15099590192242
    PMA / PMN Number
    K140911
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION IS NOT APPLICABLE. THERE WAS NO IMPACT TO PATIENTS AS A RESULT OF THIS EVENT. ONE TECHNICIAN HAD A DROP OF RETIC CLEAR REAGENT FLICK INTO HIS EYE WHILE REPLACING THE RETIC PACK. THE TECHNICIAN FLUSHED HIS EYE WITH WATER, STATING THERE WAS NO IRRITATION OR VISION ISSUE. PER LAB EXPOSURE PROTOCOL, WENT TO THE EMERGENCY DEPARTMENT (ED) TO HAVE HIS EYE CHECKED. THE ED NOTED NO REAL (EYE) DAMAGE AND PRESCRIBED THE LAB TECH AN ANTIBIOTIC. THE FAILURE MODE WAS USE ERROR; THE TECHNICIAN WAS NOT WEARING EYE PROTECTION AT TIME OF INCIDENT. THE DXH SERIES, IFU, PN: B26647AG, STATES THE FOLLOWING SAFETY NOTICE: 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 IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. BEC INTERNAL IDENTIFIER: (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED WHILE REPLACING THE RETIC PACK ON THEIR DXH 600 HEMATOLOGY INSTRUMENT, THE PICK UP TUBE FLICKED A DROP OF RETIC CLEAR REAGENT INTO THE TECHNICIAN¿S RIGHT EYE. THE TECHNICIAN WAS WEARING LAB COAT AND GLOVES (NO FACE PROTECTION) AT TIME OF EXPOSURE. THE TECHNICIAN FLUSHED HIS EYE WITH WATER, STATING THERE WAS NO IRRITATION OR VISION ISSUE. PER LAB EXPOSURE PROTOCOL, WENT TO THE EMERGENCY DEPARTMENT (ED) TO HAVE HIS EYE CHECKED. THE ED NOTED NO REAL (EYE) DAMAGE AND PRESCRIBED THE LAB TECH AN ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2211896 UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER TN DXH 600 HEMATOLOGY SYSTEM 15099590192242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other