BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2252122 · Received September 16, 2011

    Report

    Report Number
    2050012-2011-05324
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 19, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011 AND REPLACED THE NO FOAM BOTTLE ASSEMBLY AND THE ISSUE WAS RESOLVED. AS OF (B)(6) 2011, NO FURTHER NO FOAM LEAKING COMPLAINT WAS FILED. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC), AND REPORTED THAT THE TUBING AT THE TOP OF THE NO FOAM BOTTLE IS LEAKING. THE ISSUE IS ASSOCIATED WITH UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THERE WAS NO INJURY IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1