BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2001924 · Received February 27, 2011

    Report

    Report Number
    2122870-2011-00479
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COLLECTS FERRITIN SAMPLES IN BD SERUM TUBES. THE SPECIMENS ARE CENTRIFUGED AT 3,000G FOR 10 MINUTES. FERRITIN QC HAS BEEN WITHIN THE CUSTOMER'S ESTABLISHED RANGES. THERE IS NO INDICATION THAT SERVICE WAS DISPATCHED FOR THIS EVENT. 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), REGARDING LOWER THAN EXPECTED FERRITIN RESULTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR MULTIPLE PATIENTS. THE RESULTS WERE REPORTED OUT OF THE LAB. SUBSEQUENT TESTING ON TWO DIFFERENT METHODOLOGIES PRODUCED HIGHER, DISCORDANT 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 SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1