BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM

    MDR report key: 3011749 · Received March 19, 2013

    Report

    Report Number
    2050012-2013-00192
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 24, 2013
    Report Date
    February 24, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM LEAKED INSIDE THE CLOSED TUBE ALIQUOTTER (CTA) AND GENERATED QNS (QUANTITY NOT SUFFICIENT) ERROR MESSAGES. THE CUSTOMER OBSERVED FLUID NEAR THE SAMPLE RACK CAROUSEL AND TO THE LEFT ON THE BASEPLATE BELOW. THE CUSTOMER NOTED THAT THE ALIQUOT PROBE HAD STRIPPED THREADS, PREVENTING TIGHTENING OF THE PROBE. THE LEAK WAS APPROXIMATELY 50ML AND WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING GLOVES AND A LAB COAT AT THE TIME OF THE INCIDENT. THERE WAS NO REPORT OF INJURY OR EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES, AND MEDICAL ATTENTION WAS NOT SOUGHT. THE MATERIAL DATA SAFETY SHEET (MSDS) WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. THERE WAS NO IMPACT TO PATIENT RESULTS OR TREATMENT. THE CUSTOMER REQUESTED SERVICE BUT LATER CANCELLED AS THE CUSTOMER RESOLVED THE ISSUE BY REPLACING THE ALIQUOT PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114851 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