BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 PRO SYNCHRON SYSTEM

    MDR report key: 3822270 · Received May 20, 2014

    Report

    Report Number
    2050012-2014-00252
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE TROUBLESHOOTING WITH BEC HOTLINE SUPPORT, THE CUSTOMER TIGHTENED THE LOOSE FITTING ON THE PROBE. THE CUSTOMER PRIMED THE REAGENT DELIVERY SUBSYSTEM SEVERAL TIMES AND REPORTED THERE WERE NO FURTHER LEAKS.

    Description of Event or Problem · 1

    BECKMAN COULTER'S REMOTE MANAGEMENT SYSTEM DETECTED AN INSTRUMENT ERROR THAT SAID, "CC [CARTRIDGE CHEMISTRY] CUVETTE NOT DRY BEFORE FIRST REAGENT DISPENSE" AND ALERTED BECKMAN COULTER (BEC) HOTLINE SUPPORT. THE ERROR WAS RELATED TO A REAGENT PROBE ON A CUSTOMER'S UNICEL DXC 800 PRO SYNCHRON SYSTEM. HOTLINE SUPPORT CONTACTED THE CUSTOMER TO TROUBLESHOOT THE INSTRUMENT. WHILE TROUBLESHOOTING, THE CUSTOMER REPORTED A LOOSE FITTING BETWEEN A REAGENT PROBE AND ITS TUBING. THE CUSTOMER OBSERVED FLUID ON THE DRIP TRAY BENEATH THE REAGENT PROBE AND THAT A LEVEL SENSE BEAD WAS WET. THE LEAK WAS CONTAINED TO THE INSTRUMENT. THE OPERATOR WAS WEARING GLOVES, LAB COAT, AND GOGGLES. THERE WERE NO REPORTS OF DIRECT CONTACT WITH THE LEAK OR OF INJURY AS A RESULT OF THE LEAK. THE CUSTOMER REPORTED A FALSE NEGATIVE CANNABINOID (THC5) RESULT WAS GENERATED FOR ONE PATIENT AND REPORTED OUT OF THE LABORATORY. THE PATIENT SAMPLE WAS RERUN ON THE SAME INSTRUMENT AND THE RESULT WAS CORRECTED. THERE WAS NO EFFECT TO PATIENT TREATMENT DUE TO THE FALSE NEGATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300638 UNICEL DXC 800 PRO SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR