BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2827510 · Received November 9, 2012

    Report

    Report Number
    2050012-2012-01820
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012, A BEC FIELD SERVICE ENGINEER (FSE) WAS ON SITE AND REPLACED A FITTING THAT WAS PREVENTING WASTE TO EVACUATE. THE FAILURE MODE OF THE EVENT WAS OCCLUSION/OBSTRUCTION BLADE WASH DRAIN FITTING (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO REPORT RECEIVING CARTRIDGE CHEMISTRY AND MODULAR CHEMISTRY SAMPLE PROBE OBSTRUCTION ERRORS ON THEIR UNICEL DXC 600 PRO, UCTA, AND CTA READY SYNCHRON CHEMISTRY ANALYZER. IN ADDITION, THE CUSTOMER REPORTED THE CAP PIERCER IS SPRAYING AUTOGLOSS WHILE PIERCING CAPS. THE LEAK WAS CONTAINED TO THE CAP PIERCER. THE CUSTOMER CHANGED THE CAP PIERCER BLADE AND WISH, HOWEVER THE ISSUES PERSISTED. THE CUSTOMER THEN FLUSHED THE SAMPLE PROBES TO RESOLVE THE ERRORS. A BEC CUSTOMER TECHNICAL SUPPORT INSTRUCTED THE CUSTOMER TO TURN THE CAP PIERCER OFF AND DISPATCHED SERVICE TO INVESTIGATION THE INCIDENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, EYE PROTECTION, AND GLOVES WHILE INSPECTING THE LEAK. THE CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID AND DID NOT NEED TO SEEK MEDICAL ATTENTION. NO EXPOSURE (SPRAYED OR SPLASHED) TO MUCOUS MEMBRANES OR OPEN WOUNDS WERE REPORTED. THE CUSTOMER DID NOT REVIEW THE MSDS; HOWEVER, THE FACILITY DOES HAVE EXPOSURE CONTROL OR RISK MANAGEMENT PLAN IN PLACE. NO DEATH, INJURY OR CHANGES TO PATIENT TREATMENT OR RESULTS ARE ASSOCIATED WITH THIS EVENT. CUSTOMER INDICATED SHE HAS REVIEWED SAMPLE RESULTS AND THERE HAVE NOT BEEN ANY ERRONEOUS RESULTS GENERATED OR REPORTED OUT OF LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1