BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2226213 · Received August 29, 2011

    Report

    Report Number
    2122870-2011-03232
    Event Type
    Malfunction
    Date Received
    August 29, 2011
    Date of Event
    July 30, 2011
    Report Date
    July 30, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE IDENTIFIED THE SOURCE OF THE LEAK TO BE A SPLIT IN THE LATEX TUBING AT THE WASH BUFFER SUPPLY PERI-PUMP. THE FSE REPLACED THE TUBING AND RAN SYSTEM CHECK AND QC. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT A WASH BUFFER LEAK IN CONNECTION WITH THEIR UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE LEAK WAS COMING FROM THE PERI-PUMP SYSTEM. THE CUSTOMER DID NOT REPORT AN AFFECT TO PATIENTS OR END USERS IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1