BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2013443 · Received March 10, 2011

    Report

    Report Number
    2050012-2011-00629
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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) WENT ON-SITE AND EVALUATED THE INSTRUMENT. THERE WERE NO SIGNS OF CONTAMINATION, BUT THE FSE PROACTIVELY TOOK CULTURES AND THEN DECONTAMINATED THE SYSTEM AND VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ONE FALSE HIGH SODIUM (NA) RESULT OF 150MMOL/L GENERATED BY THE UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM. THE SAMPLE WAS REPEATED AND A LOWER RESULT OF 139/140MMOL/L WAS OBTAINED AND REPORTED OUTSIDE OF THE LABORATORY. 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 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JGS BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1