BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1970788 · Received January 25, 2011

    Report

    Report Number
    2122870-2011-00142
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    December 18, 2010
    Report Date
    December 28, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, CKMB QC HAS BEEN WITHIN THE CUSTOMER'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2010 AND PERFORMED A PREVENTIVE MAINTENANCE (PM) ON THE INSTRUMENT. THE FSE ALSO PERFORMED MULTIPLE ROUTINE SYSTEM CHECKS, WHICH ALL PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE CUSTOMER 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 AN ERRONEOUSLY ELEVATED CREATINE KINASE MB (CKMB) RESULT ABOVE THE NORMAL REFERENCE RANGE FOR ONE PATIENT, GENERATED BY THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY; HOWEVER, SUBSEQUENT TESTING ON THE ORIGINAL AND ON AN ALTERNATE INSTRUMENT PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. 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 600 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXI 600 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1