BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX® DELTA SYSTEM (CX9)

    MDR report key: 3151037 · Received June 6, 2013

    Report

    Report Number
    2050012-2013-00388
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K950958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND REPLACED THE REAGENT PROBE TO RESOLVE THE LEAK. FAILURE MODE IS ATTRIBUTED TO A DEFECTIVE REAGENT PROBE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBSERVING A LEAK FROM THE REAGENT PROBE OF THE SYNCHRON CX DELTA SYSTEM (CX9) WHILE RUNNING SAMPLES. THE CUSTOMER INDICATED THAT THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING A LABORATORY COAT AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250373 SYNCHRON CX® DELTA SYSTEM (CX9) COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER CX9 ALX NA

    Patients

    Seq Age Sex Outcome Treatment
    1