BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2182784 · Received July 28, 2011

    Report

    Report Number
    2122870-2011-02548
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    2050012-10/13/2011-33C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER INC. CUSTOMER TECHNICAL SERVICES REINITIALIZED THE ANALYTICAL UNIT (AU) WHICH RESOLVED THE ISSUE. THE ANALYZER'S TEMPERATURE CONTROL PROCESS IS THE LIKELY ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    BECKMAN COULTER INC. WAS NOTIFIED THAT THE CUSTOMER'S UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM HAD A DISABLED TEMPERATURE CONTROLLER. THE TEMPERATURE CONTROLLER SOFTWARE IS USED BY THE ANALYZER TO MONITOR ALL INSTRUMENT TEMPERATURES. THE CUSTOMER DID NOT RUN ANY PATIENT RESULTS FROM THE TIME THIS ISSUE BEGAN ON THE UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM AND HENCE THERE WERE NOT DEATHS, SERIOUS INJURIES OR MODIFICATIONS TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. NO SPECIFIC PATIENT INFORMATION OR SAMPLE COLLECTION/HANDLING INFORMATION WAS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1