BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 2080816 · Received May 6, 2011

    Report

    Report Number
    2122870-2011-01306
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 8, 2011
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION HAVE NOT BEEN SUPPLIED TO DATE. QC DATA INDICATE THAT BOTH LEVELS OF HAV-IGM QC HAVE BEEN WITHIN THE CUSTOMER'S ESTABLISHED RANGE FOR THE PAST 30 DAYS. CUSTOMER IS SENDING SAMPLE TO CUSTOMER PRODUCT LINE SUPPORT (CPSL) EAST FOR ADDITIONAL TESTING. SAMPLE HAS NOT YET BEEN RECEIVED. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT, WITH THE DATA PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT OBTAINING REPRODUCIBLE REACTIVE HAV IGM RESULTS 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 TWO DIFFERENT METHODOLOGIES PRODUCED DISCORDANT, NON-REACTIVE 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 ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXI 800

    Patients

    Seq Age Sex Outcome Treatment
    1