BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 1951683 · Received January 6, 2011

    Report

    Report Number
    2122870-2010-01004
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    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

    THE SAMPLES WERE CENTRIFUGED AT 3000G FOR FIVE MINUTES AT 18ºC. QC HAD BEEN WITHIN THE ESTABLISHED RANGES. THE RESULTS OF SYSTEM CHECK WERE ACCEPTABLE. THERE IS NO INDICATION THAT A SERVICE WAS DISPATCHED FOR THIS EVENT. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO FALSE POSITIVE HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG) RESULTS GENERATED BY UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER FOR ONE PATIENT. SUBSEQUENT TESTING ON THE SAME INSTRUMENT AND BY AN ALTERNATE METHOD PRODUCED NEGATIVE 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1