BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2091516 · Received May 17, 2011

    Report

    Report Number
    2050012-2011-01572
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO AND AFTER THE EVENT WAS WITHIN THE LAB'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND REPLACED A LEAKING EIC (ELECTROLYTE INJECTION CUP) VALVE AND ALSO DECONTAMINATED THE SYSTEM DUE TO A DIRTY FLOWCELL. FSE VERIFIED INSTRUMENT PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING LOW SODIUM (NA) RESULTS ON 9 PATIENT SAMPLES GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. WHEN THE CUSTOMER NOTICED LOW ANION GAPS, THE SAMPLES WERE REPEATED ON A DIFFERENT INSTRUMENT IN THE LABORATORY WHICH GAVE HIGHER RESULTS AND THEY WERE REPORTED OUTSIDE OF THE LABORATORY. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN IN THE ATTACHMENT. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1