BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX9 ALX CLINICAL SYSTEM

    MDR report key: 1840463 · Received September 21, 2010

    Report

    Report Number
    2050012-2010-00820
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 21, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) FOUND THAT THE SAMPLE SYRINGE WAS LEAKING FROM THE GLASS BARREL. FSE ORDERED A NEW SYRINGE ASSEMBLY FOR THE CUSTOMER TO REPLACE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A LEAKING SYRINGE ON SYNCHRON CX9 ALX CLINICAL SYSTEM. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX9 ALX CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1