BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2218132 · Received August 22, 2011

    Report

    Report Number
    2050012-2011-04658
    Event Type
    Malfunction
    Date Received
    August 22, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 2011
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4)-2011 A BEC FIELD SERVICE ENGINEER (FSE) NOTED THE EIC AND ION-SELECTIVE ELECTRODE (ISE) DRAIN WERE OVERFLOWING INDICATING AN ISSUE WITH THE ISE VACUUM. FSE ENABLED THE MODULAR CHEMISTRY SIDE AND HOMED. THE ISE DRAIN HAD BEEN FULL AND IT DRAINED. FSE PRIMED 20X WITH NO OVERFLOWS. FSE CHECKED EIC, VACUUM DRAIN LINES AND ISE DAMPER FOR BLOCKAGES AND FOUND NONE. PRIMED 250 ML OF 25% WARM BLEACH THRU THE VACUUM DRAIN LINE. CALIBRATED AND RAN PRECISIONS TO TEST. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT THAT THE ELECTROLYTE INJECTION CUP (EIC) OVERFLOWED ON THE UNICEL DXC 800P SYNCHRON CHEMISTRY ANALYZER. PER CUSTOMER, NO PATIENT RESULTS HAVE BEEN AFFECTED BY THIS EVENT. NO INJURY OR EXPOSURE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1