BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1982447 · Received February 9, 2011

    Report

    Report Number
    2122870-2011-00218
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    September 1, 2010
    Report Date
    January 13, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LFX
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC AND SYSTEM INFORMATION ARE NOT AVAILABLE. SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION HAS NOT BEEN PROVIDED. SERVICE WAS NOT DISPATCHED. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING A REACTIVE RUBELLA IGM RESULT FOR ONE PATIENT WHICH WAS DISCORDANT TO ANOTHER METHODOLOGY, GENERATED ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. UNKNOWN IF PATIENT TREATMENT WAS IMPACTED BY THIS EVENT. THE EVENT OCCURRED SOMETIME BETWEEN (B)(6) 2010 AND (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER LFX BECKMAN COULTER INC. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR