BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 1863302 · Received October 9, 2010

    Report

    Report Number
    2122870-2010-00609
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Date of Event
    September 2, 2010
    Report Date
    October 8, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS NOT FLAGGED AS OUT OF THE CUSTOMER'S ESTABLISHED RANGES AND SHOWED GOOD PRECISION. THERE WAS NO FLAG ASSOCIATED WITH THE RESULTS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. NO CLEAR ROOT CAUSE FOR THE EVENT HAS BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A SHIFT UP IN FREE T4 (FT4) QC AND PATIENT RESULTS WHEN A NEW LOT OF CALIBRATOR WAS PUT INTO USE ON UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. REVIEW OF THE DATA SHOWED THAT EIGHT PATIENT RESULTS CROSSED CLINICAL RANGES. 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1