BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2001970 · Received February 27, 2011

    Report

    Report Number
    2050012-2011-00533
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 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
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE AND REPLACED THE PERI-PUMP TUBING AND VERIFIED INSTRUMENT PERFORMANCE. THE ISSUE HAS BEEN RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THE CLOSED TUBE ALIQUOTTER (CTA) OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM HAD A LEAK UNDERNEATH THE WASH STATION. THE CUSTOMER OBSERVED CRYSTAL BUILDUP AND COULD SEE LIQUID FLOWING WHEN PROBE WAS PRIMED. NO INJURY WAS REPORTED.

    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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1