BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2233750 · Received September 3, 2011

    Report

    Report Number
    2122870-2011-03357
    Event Type
    Malfunction
    Date Received
    September 3, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 TO ADDRESS THE ISSUE. THE FIELD SERVICE ENGINEER (FSE) DISCOVERED A "BRIDGE" IN THE INTERLOCK SWITCH. IT APPEARED TO BE A METAL PAPER CLIP AND WAS NOT A BECKMAN COULTER INC. INTERLOCK BYPASS TOOL. THE "BRIDGE" WAS USED TO OVERRIDE THE INTERLOCK CIRCUIT AND ALLOWED THE MOTORS TO BE ENGAGED WHILE THE COVERS WERE OPENED. THE FSE REMOVED THE "BRIDGE" AND THE INTERLOCK SWITCH RETURNED TO NORMAL OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 IT WAS DISCOVERED WHILE PERFORMING MAINTENANCE ON THEIR UNICEL DXL 600 ACCESS IMMUNOASSAY SYSTEM THAT THE INTERLOCK SWITCH FOR THE UNIT WAS NOT DISENGAGING THE MOTORS. THE MOTORS WERE STILL ENGAGED WHILE THE INSTRUMENT COVER WAS OPEN. NO INJURIES WERE REPORTED AND NO PERSONNEL SOUGHT ANY MEDICAL ATTENTION IN ASSOCIATION WITH THIS EVENT. NO PATIENT RESULTS WERE AFFECTED BY THIS EVENT. NO DEATH, INJURY OR MODIFICATION TO PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1