BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 1951818 · Received January 7, 2011

    Report

    Report Number
    2050012-2011-00084
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER NOTED LEAKING FROM THE CTA WASH STATION. QC WAS NOT PROVIDED BY THE CUSTOMER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2010 AND REPLACED THE ACTIVE WASH STATION WASTE DRAIN LINE TO THE PERI PUMP TUBING. THE FSE ALSO PRIMED ALIQUOT PROBE AND OBSERVED FOR LEAKING OR OVERFLOW. THE FSE CLEANED UP THE CTA AND RAN SAMPLES; NO LEAKING OR OVERFLOW OCCURRED. THE HARDWARE REPAIRS RESOLVED THE ISSUES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING LEAKING IN THE CLOSED TUBE ALIQUOTTER (CTA) THAT MAY HAVE RESULTED IN ERRONEOUSLY HIGH ACCESS I RESULTS THAT WERE GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER DID NOT PROVIDE ANY SPECIFIC PATIENT DATA INFORMATION. HOWEVER, THE CUSTOMER INDICATED THAT ONLY ONE SAMPLE RESULT WAS AFFECTED, WHICH THE CHEMISTRY WAS UNKNOWN, BUT THE DIFFERENCE WAS PROBABLY LESS THAN 10% FROM THE CORRECTED RESULTED. THE INCORRECT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND NO OPERATOR EXPOSURE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1