BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2028131 · Received March 23, 2011

    Report

    Report Number
    2122870-2011-00685
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 22, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LTJ
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN SPECIFICATIONS PRIOR TO AND AFTER THE EVENT. SERVICE WAS NOT REQUESTED FOR THIS EVENT AS THE CUSTOMER IS NOT QUESTIONING INSTRUMENT PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. REGARDING A HIGHER THAN EXPECTED HYBRITECH PSA (PROSTATE SPECIFIC ANTIGEN) RESULT GENERATED BY THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM THAT DID NOT MATCH THE HYBRITECH PSA RESULT FOR ONE PATIENT. THE INITIAL RESULT WAS 0.30NG/ML AND WHEN SAMPLE WAS TREATED IN A HETEROPHILE BLOCKING TUBE (HBT), IT GAVE A RESULT OF <0.1NG/ML. UPON TESTING ON AN ALTERNATE METHODOLOGY, THE SAMPLE GAVE A RESULT OF 0.006. 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 LTJ BECKMAN COULTER INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1