BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1971281 · Received January 26, 2011

    Report

    Report Number
    2050012-2011-00259
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 28, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2010 AND DETERMINED THAT THE ISSUE INVOLVED A TRANSDUCER FAILURE AND THE MEMBRANE RUPTURED. THE FSE REPLACED THE SMART MODULE, TRANSDUCER, PROBE, AND TUBING. THE FSE ALSO PERFORMED ALL THE NECESSARY ADJUSTMENTS AND ALIGNMENTS ON THE SYSTEM AND THE QC RESULTS RECOVERED WITHIN ACCEPTABLE RANGE. THIS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT FLUID WAS LEAKING FROM THE MODULE CHEMISTRY (MC) SAMPLE PROBE LOCATED IN THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER DISABLED THE MC SIDE OF THE SYSTEM. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1