BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2211686 · Received August 5, 2011

    Report

    Report Number
    2122870-2011-02715
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 9, 2008
    Report Date
    June 9, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    Z-0914-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) SERVICED THE UNIT AT THE FACILITY ON (B)(6) 2008 AND DISCOVERED THE PERISTALTIC PUMP WAS FAULTY (CHIPPING OF THE EDGES OF THE CASSETTES THAT HOLD THE PERI-TUBING) AND REPLACED THE PERISTALTIC PUMP. THE PERI-TUBING WAS REPLACED ON (B)(6) 2008. THE UNIT CONFIRMED TO THE MFR'S SPECIFICATIONS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM (B)(6) 2008 THROUGH (B)(6) 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED QUALITY CONTROL (QC) WAS OUT OF RANGE WITH HIGH RELATIVE LIGHT UNITS (RLU'S) INVOLVING UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM. THERE WAS NO PT IMPACT. THE FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY AND ASSESSED THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA