BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2016317 · Received March 11, 2011

    Report

    Report Number
    2122870-2011-00633
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE ONLY PATIENT SAMPLE BEING QUESTIONED. NO QC OR SYSTEM CHECK DATA WAS SUPPLIED. THERE IS NO INDICATION THAT SERVICE WAS DISPATCHED FOR THIS EVENT. THE PATIENT'S SAMPLE IS BEING SENT TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR AN INTERFERENT TESTING. ROOT CAUSE FOR THIS EVENT IS PENDING CPLS INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING OBTAINING HIGHER THAN EXPECTED RESULT FOR GI MONITOR THAT WAS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULT WAS DISCORDANT TO TWO ALTERNATIVE METHODS. THE RESULTS WERE 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 WITH 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 38 YR