BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1022614 · Received March 31, 2008

    Report

    Report Number
    2122870-2008-00098
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    January 3, 2008
    Report Date
    March 31, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC DATA WAS NOT PROVIDED. PRE-ANALYTICAL SAMPLE HANDLING INFORMATION WAS NOT SUPPLIED. THE CUSTOMER QUESTIONED ONLY THE TSH RESULTS. THE SPECIMENS WERE NOT SENT AND ARE NO LONGER AVAILABLE FOR TESTING BY BCI. A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED FOR THIS EVENT. THERE IS NO SUFFICIENT INFORMATION FROM THE CUSTOMER TO DETERMINE WHICH TSH RESULTS ARE CORRECT. IF A TSH RESULT IS ERRONEOUSLY NORMAL, THERE IS THE POTENTIAL FOR TREATMENT OR FURTHER EVALUATION TO BE DELAYED WHICH COULD RESULT IN A HEALTH RISK TO THE PATIENT. NO ADDITIONAL INFORMATION REGARDING THIS EVENT IS AVAILABLE, AND THE ROOT CAUSE OF THE EVENT IS UNKNOWN AT THIS TIME. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) REGARDING DISCREPANT HUMAN THYROID-STIMULATING HORMONE (TSH) RESULTS THAT WERE GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR MULTIPLE PATIENTS. PATIENT A: AN INITIAL RESULT WAS 0.046MIU/L. THE SAMPLE WAS RETESTED SEVERAL TIMES AND RESULTS WERE IN THE RANGE OF 0.048 - 1.142MIU/L. PATIENT B: AN INITIAL RESULT WAS 0.389MIU/L. THE SAMPLE WAS RETESTED 3 TIMES AND REPEATED RESULTS WERE IN THE RANGE OF 0.04 - 0.042MIU/L. PATIENT C: AN INITIAL RESULT WAS 0.154MIU/L. THE SAMPLE WAS RETESTED TWICE AND REPEATED RESULTS WERE: 0.539MIU/L AND 0.193MIU/L. PATIENT D: AN INITIAL RESULT WAS 0.035MIU/L AND REPEATED RESULTS WERE IN THE RANGE OF 0.231 - 0.404MIU/L. IT IS UNKNOWN WHICH TSH RESULTS WERE REPORTED OUT OF THE LAB. THERE HAS BEEN NO REPORT OF INJURY OR CHANGE IN PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA