BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX5 DELTA CLINICAL SYSTEM

    MDR report key: 2940034 · Received February 1, 2013

    Report

    Report Number
    2050012-2013-00070
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 6, 2013
    Report Date
    January 6, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW REAGENT SYRINGE VALVE WAS ORDERED AND SHIPPED TO THE CUSTOMER. THE FSE GUIDED THE CUSTOMER IN THE INSTALLATION OF THE SYRINGE VALVE AND RESOLVED THE ISSUE. SYSTEM VERIFICATION WAS COMPLETED. THE INSTRUMENT WAS RETURNED TO OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THE CUSTOMER ALLEGED FLUID LEAKED FROM THE REAGENT SYRINGE 3-WAY VALVE INVOLVING THE SYNCHRON CX5 DELTA CLINICAL SYSTEM. THE CUSTOMER HAD ON PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND EYE PROTECTION AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED, AND THERE WAS NO PATIENT IMPACT. THE CUSTOMER REPLACED THE REAGENT SYRINGE AND PROBE BUT DID NOT RESOLVE THE ISSUE. THERE IS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44298 SYNCHRON® CX5 DELTA CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1