BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2003436 · Received March 1, 2011

    Report

    Report Number
    2050012-2011-00592
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 2, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MZV
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND AND REPLACED A CRACKED ELECTROLYTE INJECTOR CUP (EIC) VALVE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A POTASSIUM (K) RESULT OF 3.4MMOL/L THAT WAS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM AND REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS RERUN THE NEXT DAY AND RESULTS OF 3.7MMOL/L AND 3.8MMOL/L WERE OBTAINED. THE DIFFERENCE IN THE RESULTS WAS WITHIN THE PRECISION OF THE ASSAY BUT THE CUSTOMER AMENDED THE REPORT. THERE WAS NO AFFECT TO PATIENT TREATMENT WITH REGARD TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1