BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2222170 · Received August 24, 2011

    Report

    Report Number
    2122870-2011-02956
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 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
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLE WAS COLLECTED IN LIHEP PLASMA SAMPLE TUBES, CENTRIFUGED FOR 10 MINUTES AT 3500 RPM. QC WAS PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED RANGES AT THE TIME OF THE EVENT. SYSTEM CHECK DATA WAS NOT SUPPLIED BY THE CUSTOMER. ON (B)(4) 2011, A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THE EVENT. THE FSE COMPLETED ON SITE SERVICE WITH NO DETECTABLE MALFUNCTION RELATED TO THE VENT. THE FSE REPORTED ALL DIAGNOSTIC TESTING PERFORMED PASSED WITHIN INSTRUMENT SPECIFICATIONS. A CLEAR ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. RELATED MDR: 2122870-2011-02957.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) QUESTIONING ELEVATED HUMAN THYROID-STIMULATING HORMONE (HTSH) RESULT ABOVE THE NORMAL REFERENCE RANGE FOR ONE (1) PATIENT. THE RESULT WAS GENERATED BY A UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM, USED IN CONJUNCTION WITH ACCESS HYPERSENSITIVE HTSH REAGENT (LOT 170013). THE SAMPLE WAS DRAWN FROM THE PATIENT'S IV LINE. ANOTHER SAMPLE WAS DRAWN FROM THE PATIENT BY A PHLEBOTOMIST. TESTING OF THIS SAMPLE ON THE SAME INSTRUMENT PRODUCED LOWER HTSH RESULTS WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY. THE CUSTOMER DID NOT QUESTION THESE RESULTS. IT IS UNKNOWN IF THERE WERE ANY CHANGES TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR