BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2232117 · Received September 1, 2011

    Report

    Report Number
    2050012-2011-04772
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 6, 2011
    Report Date
    August 6, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LOOSE WASH SYRINGE CAUSED THE LEAKING ON THE SYSTEM. BEC CTS (CUSTOMER TECHNICAL SUPPORT) ADVISED THE CUSTOMER TO TIGHTEN THE SYRINGE AND PRIME THE SYSTEM WHICH RESOLVED THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FLAGGED LEVEL SENSE ERRORS ON THE CTA (CLOSED TUBE ALIQUOTTER) AND THE WASH SYRINGE WAS LEAKING. NO INJURY OR EXPOSURE WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    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