BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2067042 · Received April 22, 2011

    Report

    Report Number
    2122870-2011-01028
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFP QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE EVENT AND OUT OF RANGE HIGH AFTER THE EVENT. SERVICE WAS DISPATCHED AND FOUND THAT THE DILUTION CORRECTION FACTORS FOR DIL-AFP WERE FOUND TO BE TEN TIMES GREATER THAN THE ACCEPTABLE RANGE. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT AND IS STILL BEING INVESTIGATED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING A HIGHER THAN EXPECTED ALPHA-FETOPROTEIN (AFP) RESULT GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. SUBSEQUENT TESTING ON AN ALTERNATE INSTRUMENT PRODUCED A LOWER RESULT THAT MATCHED THE PATIENT'S CLINICAL PRESENTATION. THE HIGH 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