BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 1941306 · Received December 29, 2010

    Report

    Report Number
    2122870-2010-00987
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 30, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED FROM A SATELLITE FACILITY. QC IS PERFORMED ONCE DAILY AND WAS WITHIN SPECIFICATIONS DURING THIS EVENT. SERVICE WAS OFFERED BUT WAS DECLINED BY THE CUSTOMER. A DEFINITIVE ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO AN ERRONEOUSLY ELEVATED THYROID STIMULATING HORMONE (HTSH) RESULT ABOVE THE REFERENCE RANGE GENERATED BY UNICEL DXI 600 ACCESS IMMUNOASSAY ANALYZER FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. BECAUSE THE SAMPLE WAS NOT AVAILABLE FOR RE-TESTING, THE PATIENT HAD A SUBSEQUENT SAMPLE DRAWN. THE TESTING ON THE SUBSEQUENT SAMPLE PRODUCED A RESULT WITHIN THE NORMAL REFERENCE RANGE AND BETTER MATCHED THE PATIENT'S CLINICAL PICTURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR