BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3183328 · Received June 21, 2013

    Report

    Report Number
    2050012-2013-00426
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 26, 2013
    Report Date
    May 26, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER TROUBLESHOOTING, THE CUSTOMER REVEALED A LOOSE REAGENT PROBE B FITTING ON TOP OF THE LEAKING PROBE. THE CUSTOMER RESOLVED THE ISSUE BY TIGHTENING THE LOOSE FITTING FOUND ON TOP OF REAGENT PROBE B. THE CUSTOMER ALSO REPLACED THE AST REAGENT CARTRIDGE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER RESOLVED THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL INSTRUMENT WAS GENERATING "CHEMISTRY CARTRIDGE (CC) CUVETTE NOT DRY BEFORE 1ST REAGENT DISPENSE" ERRORS. UPON TROUBLESHOOTING WITH BEC HOTLINE SUPPORT, THE CUSTOMER OBSERVED THAT REAGENT PROBE B WAS LEAKING INTO THE DRIP TRAY. IN ADDITION, THE CUSTOMER DISCOVERED LIQUID ON TOP OF THE ASPARTATE AMINOTRANSFERASE (AST) REAGENT CARTRIDGE WHICH ATTRIBUTED TO THE LEAKING REAGENT PROBE. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND PROTECTIVE EYEWEAR AT THE TIME OF THE INCIDENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THERE IS AN EXPOSURE CONTROL / RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283587 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1