BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1961993 · Received January 17, 2011

    Report

    Report Number
    2122870-2011-00029
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS LITHIUM HEPARIN PLASMA THAT WAS CENTRIFUGED FOR 10 MINUTES. THE CUSTOMER WAS NOT HAVING ANY ISSUES WITH QC. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE PERFORMED A DIAGNOSTIC TESTING AND THE CARRYOVER PROCEDURE; BOTH MET SPECIFICATIONS. THE FSE PERFORMED QC WHICH WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES. NO HARDWARE ISSUES WERE NOTED. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC, (BCI) REGARDING THYROID-STIMULATING HORMONE (TSH) RESULTS BELOW THE NORMAL REFERENCE RANGE GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR THREE PATIENTS' SAMPLES. SUBSEQUENT TESTING PERFORMED ON A DIFFERENT INSTRUMENT PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE RESULTS WERE REPORTED OUT OF THE LAB. 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® DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1