BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1897064 · Received November 11, 2010

    Report

    Report Number
    2122870-2010-00759
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 13, 2010
    Report Date
    November 11, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED IN A PLASTIC BD LIGHT GREEN TOPPED PLASMA TUBE WITH A GEL SEPARATOR. THE CUSTOMER IS NOT QUESTIONING ANY OTHER RESULT OR ASSAY AT THIS TIME. SERVICE WAS OFFERED BY CUSTOMER TECHNICAL SERVICE (CTS) AT THE TIME OF THE CALL BUT THE CUSTOMER DECLINE TO HAVE AN ENGINEER ON-SITE. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING AN ELEVATED CKMB RESULT GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. SUBSEQUENT TESTING ON AN ALTERNATE ANALYZER PRODUCED A LOWER RESULT WITHIN THE NORMAL REFERENCE RANGE. THE RESULT WAS NOT REPORTED OUT OF THE LAB. 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. NA

    Patients

    Seq Age Sex Outcome Treatment
    1