BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2030071 · Received March 25, 2011

    Report

    Report Number
    2122870-2011-00792
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    August 4, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN SPECIFICATIONS PRIOR TO AND AFTER THE EVENT. THERE IS NO INDICATION THAT SERVICE WAS DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A REACTIVE TOXO IGG RESULT OF 15.5IU/ML GENERATED BY THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM THAT DID NOT MATCH THE CLINICAL PICTURE AND WAS QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS ANALYZED BY BCI CPLS (CUSTOMER PRODUCT LINE SUPPORT) AND RESULTED AS NON-REACTIVE. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1