BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2150043 · Received July 5, 2011

    Report

    Report Number
    2122870-2011-02137
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    OMI
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION HAVE NOT BEEN SUPPLIED TO DATE. PER THE CUSTOMER SUPPLIED QC DATA, CMV-IGG QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGE THE DAY OF THE EVENT AND AFTER THE EVENT. ADDITIONAL SYSTEM INFORMATION HAS NOT BEEN SUPPLIED TO DATE. CUSTOMER PRODUCT LINE SUPPORT (CPLS) TESTING OF PATIENT'S SAMPLES TENDED TO (B)(6) PRESENCE OF CMV IGG. A CLEAR ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO REPORT OBTAINING A (B)(6) CYTOMEGALOVIRUS IMMUNOGLOBULIN G (CMV-IGG) RESULT FOR ONE (1) PATIENT, GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE RESULT WAS REPORTED OUT OF THE LAB. SUBSEQUENT TESTING OF THE PATIENT'S SAMPLE ON AN ALTERNATE METHODOLOGY GENERATED A "(B)(6)" RESULT. THE PATIENT'S SECOND SAMPLE WAS ANALYZED ON AN ALTERNATE DXI INSTRUMENT ON (B)(6) 2011 AND RESULTS WERE ALSO (B)(6). 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 FOR CLINICAL USE OMI BECKMAN COULTER INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1