BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM

    MDR report key: 3062223 · Received April 16, 2013

    Report

    Report Number
    2050012-2013-00259
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION AND TROUBLESHOOTING WERE PERFORMED BY THE CUSTOMER. THE CUSTOMER REPORTED REPLACING THE SAMPLE SYRINGE AND NO FURTHER LEAKS OR ISSUES WERE OBSERVED. NO SERVICE WAS REQUESTED AND A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED FOR THIS EVENT. FAILURE MODE IS ATTRIBUTED TO THE CTA SAMPLE SYRINGE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CONTAINED LEAK FROM THE CTA (CLOSED-TUBE ALIQUOTER) SAMPLE SYRINGE INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER INDICATED OBSERVING BUBBLES IN THE LINE AND LEAK FROM THE SAMPLE ALIQUOT PROBE. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT AND GOGGLES AND NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163129 UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1