BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2110816 · Received June 1, 2011

    Report

    Report Number
    2050012-2011-01945
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 7, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO AND AFTER THE EVENT WAS WITHIN THE LABORATORY'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE PRIOR TO THIS EVENT FOR A DIFFERENT ISSUE AND DIS-ASSEMBLED AND EXAMINED THE ION-SELECTIVE ELECTRODE (ISE) SYSTEM AND NO ISSUES WERE FOUND. FSE RE-ASSEMBLED AND VERIFIED PERFORMANCE. FSE WENT ON-SITE AFTER THIS EVENT, RE-EXAMINED THE SYSTEM AND AGAIN FOUND NO ISSUES. PERFORMANCE WAS VERIFIED. PER FSE, PRE-ANALYTICAL VARIABLES ARE SUSPECTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSE HIGH SODIUM (NA), CHLORIDE (CL), CALCIUM (CA) AND CO2 RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM DURING THE NIGHT SHIFT OF (B)(6) 2011 -(B)(6) 2011. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE REPEATED ON A DIFFERENT INSTRUMENT WHICH GAVE LOWER RESULTS AND THOSE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

    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. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1