BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1935581 · Received December 22, 2010

    Report

    Report Number
    2050012-2010-01710
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 30, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO AND AFTER THE EVENT WAS WITHIN THE LAB'S ESTABLISHED RANGES. SERVICE HAS BEEN INITIATED TO VERIFY INSTRUMENT PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSE HIGH SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL) RESULTS FOR ONE PATIENT SAMPLE GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE INSTRUMENT PERFORMED AN AUTOMATIC CRITICAL RERUN WITH LOWER RESULTS. THE SAMPLE WAS RERUN ON AN ALTERNATE INSTRUMENT WHICH CONFIRMED THE LOWER RESULTS. 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 JGS BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1