BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2140215 · Received June 25, 2011

    Report

    Report Number
    2122870-2011-02059
    Event Type
    Malfunction
    Date Received
    June 25, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 26, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ANALYZES PATIENT SAMPLES FROM 13X75MM PLASTIC ALIQUOT TUBES. ALL OTHER TESTING (QC, CALIBRATIONS AND CORRELATIONS) WAS DONE FROM 0.5ML SAMPLE CUPS. QC HAS BEEN WITHIN THE CUSTOMER'S ESTABLISHED RANGES. BCI CTS OFFERED TO SET UP A SERVICE VISIT BUT THE CUSTOMER DECLINED THE OFFER. A PREVENTIVE MAINTENANCE (PM) WAS PERFORMED ON THIS INSTRUMENT ON (B)(4) 2011.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING IMPRECISE UNCONJUGATED ESTRIOL RESULTS FOR ONE PATIENT GENERATED BY THE UNICEL DXL 600 ACCESS IMMUNOASSAY SYSTEM THAT WERE OUTSIDE OF THE STATED PRECISION CLAIMS FOR THE ASSAY. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1