BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2252056 · Received September 16, 2011

    Report

    Report Number
    2050012-2011-05345
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 25, 2011
    Report Date
    August 25, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011. FSE FLUSHED THE CAP PIERCER WASH LINE WITH BLEACH TO CORRECT CAP PIERCER LEAKING ISSUE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED IN REPORTING THAT THE CTS BLADE WASH OF A UNICEL DXC 800 SYNCHRON SYSTEM WAS LEAKING ONTO THE SAMPLE TUBE CAPS. THE LEAK WAS DESCRIBED AS A DROP OR TWO OF LIQUID THAT WAS HAPPENING INTERMITTENTLY. NO ONE WAS EXPOSED OR INJURED AS A RESULT OF THE LEAK CUSTOMER TECHNICAL SUPPORT INSTRUCTED CUSTOMER TO DISABLE THE CAP PIERCER AND TO NOT OPERATE THE INSTRUMENT UNTIL REPAIRED. CUSTOMER REPORTED A TOTAL OF FOUR OR FIVE SAMPLES THAT HAD LIQUID ON THE CAP. CUSTOMER REPEATED THREE OF THE SAMPLES THAT HAD LIQUID ON THE CAP USING ANOTHER INSTRUMENT (LX20 PRO) AND CONCLUDED THAT THE RESULTS WERE NOT AFFECTED BY THE LEAK. NO ERRONEOUS RESULTS WERE GENERATED OR REPORTED OUT OF THE LAB.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1