BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2032115 · Received March 28, 2011

    Report

    Report Number
    2122870-2011-00859
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    July 26, 2008
    Report Date
    July 30, 2008
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES COLLECTED WERE A COMBINATION OF SERUM AND LIHEPARIN PLASMA. BCI CPLS (CUSTOMER PRODUCT LINE SUPPORT) TESTING DETERMINED AN INTERFERENT IN THE PATIENT'S SAMPLE IS THE ROOT CAUSE FOR THE ELEVATED RESULTS. THE CUSTOMER DID NOT REPORT ANY ISSUES WITH THE SYSTEM. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(6) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ELEVATED TROPONIN (ACCUTNI) RESULTS GENERATED BY THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND THE PATIENT HAD A CARDIAC CATHERIZATION PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other