BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1853360 · Received October 5, 2010

    Report

    Report Number
    2122870-2010-00592
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 7, 2010
    Report Date
    October 4, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE AND PERFORMED A ROUTINE SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE FSE DID NOT NOTE ANY HARDWARE ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING HIGHER THAN EXPECTED GI MONITOR RESULTS ABOVE THE NORMAL REFERENCE RANGE FOR FOUR PATIENTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. SUBSEQUENT TESTING WAS REPEATED FOR ALL FOUR PATIENTS AND ALL RESULTS WERE IN NORMAL RANGE. THE ORIGINAL ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY, BUT AMENDED BY THE REPEATED RESULTS. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1