BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2143703 · Received June 29, 2011

    Report

    Report Number
    2122870-2011-02080
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SYSTEM CHECK WAS RUN FOLLOWING THE ERRONEOUS RESULT WHICH FAILED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE (B)(4) 2011 AND FOUND A DISPENSE PROBE HAD A HOLE IN IT. FSE REPLACED THE DISPENSE PROBE AND VERIFIED SYSTEM PERFORMANCE TO PUBLISHED SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A FALSE TROPONIN (ACCUTNI) RESULT GENERATED BY THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THERE WAS A CHANGE TO PATIENT TREATMENT. HOWEVER, THE SPECIFIC TREATMENT RECEIVED WAS NOT PROVIDED. 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 MMI BECKMAN COULTER INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1