BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2243967 · Received August 19, 2011

    Report

    Report Number
    2122870-2011-02974
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    May 1, 2005
    Report Date
    August 25, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. THIS EVENT OCCURRED IN (B)(6) 2005. ADD'L EVENT INFO, FROM THE AFFILIATE, IS NOT AVAILABLE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM (B)(6) 2008 THROUGH (B)(6) 2010 FOR ADD'L REPORTABLE EVENTS. THIS MEDWATCH REPORT IS RELATED TO MDRS: 2122870-2011-02975, 02976, 02977, 02978, 02979, 02980, 02981.

    Description of Event or Problem · 1

    THE AFFILIATE ALLEGED THE CUSTOMER REPORTED CONSISTENTLY ELEVATED THYROID-STIMULATING HORMONE (TSH) RESULTS, ABOVE THE NORMAL REFERENCE RANGE, FOR ONE PT INVOLVING UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM. THIS IS REPORT NUMBER ONE OF EIGHT. THE ELEVATED TSH RESULT DID NOT CORRELATE WITH THE PT'S CLINICAL CONDITION. IT IS UNK IF THE ELEVATED RESULT WAS RELEASED OUT OF THE LABORATORY. THERE HAS BEEN NO REPORT OF PT INJURY OR CHANGE IN PT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR ACCESS HYPERSENSITIVE HTSH