BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2I (LXI) IMMUNOASSAY SYSTEM

    MDR report key: 2063697 · Received April 20, 2011

    Report

    Report Number
    2122870-2011-01049
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 20, 2011
    Report Date
    March 20, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PERFORMED MULTIPLE ROUTINE SYSTEM CHECKS WHICH FAILED. THE CUSTOMER STATED TO CUSTOMER TECHNICAL SUPPORT (CTS) THAT THERE WERE VACUUM UNDER LIMIT ERRORS POSTING TO THE EVENT LOG. CTS ASSISTED THE CUSTOMER IN TROUBLESHOOTING THE VACUUM SYSTEM AND NOTED THAT THE VACUUM PRESSURE WOULD NOT REGISTER. THE CTS HAD THE CUSTOMER REBOOT THE INSTRUMENT AND THE CUSTOMER STATED THAT THEY NOTICED A BURNING SMELL. CTS RECOMMENDED THAT THE CUSTOMER POWER DOWN AND UNPLUG THE INSTRUMENT AND WAIT FOR SERVICE. A BCI FIELD SERVICE ENGINEER) FSE) INSPECTED THE INSTRUMENT BUT DID NOT FIND ANY EVIDENCE OF DAMAGE AND/OR FIRE. FSE REPLACED THE VACUUM PUMP AS IT HAD COMPLETELY FAILED. FSE PRIMED THE SYSTEM AND PERFORMED A ROUTINE SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A BURNING SMELL FROM THE ACCESS 2I (LXI) IMMUNOASSAY SYSTEM. NO FLAMES, FIRE, AND/OR INJURY TO USER WERE REPORTED. THE CUSTOMER DID NOT SEEK OR NEED MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2I (LXI) IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. ACCESS2 LXI N/A

    Patients

    Seq Age Sex Outcome Treatment
    1