BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2142163 · Received May 26, 2011

    Report

    Report Number
    2122870-2011-01438
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    December 16, 2008
    Report Date
    December 16, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BCI OFFERED TO EVALUATE/SERVICE THE INSTRUMENT; HOWEVER, THE CUSTOMER DECLINED THIS OFFER. ACCORDINGLY, NO SYSTEM EVAL COULD BE PERFORMED. A SAMPLE FROM THE PT WAS SENT TO THE CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR ADDITIONAL TESTING. CPLS INVESTIGATION OF SAMPLES RECEIVED REVEALED THAT SAMPLE SIGNAL (NEAT AND DILUTED) WAS IMPACTED BY AN INTERFERENCE WHICH LIKELY RELATES TO ALKALINE PHOSPHATASE. THIS INTERFERING COMPOUND, DISTINCT FROM HETEROPHILE ANTIBODIES CAUSES REPRODUCIBLE FALSE POSITIVE RESULTS. SIMILAR TO HETEROPHILE ANTIBODIES INTERFERENCE, THE RESULTS DO NOT CORRELATE WITH THE CLINICAL STATUS OF THE PT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 THROUGH (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) ON (B)(6) 2008, IN REGARDS TO ELEVATED ACCUTNI RESULTS GENERATED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PT. THE PT SAMPLE WAS TESTED ON A DIFFERENT INSTRUMENT AND THE RESULTS WERE ELEVATED. AN ALTERNATE METHODOLOGY WAS USED TO TEST THE PT SAMPLE FOR TROPONIN AND RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. CUSTOMER RAN THE SAMPLE IN A SCANTIBODIES TUBE AND RECOVERED TWICE THE VALUE. THE INITIAL ELEVATED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE ARE NO REPORTS OF ANY ADVERSE PT CONSEQUENCE OR CHANGE TO THE PATIENT'S TREATMENT. THERE ARE NO INDICATIONS OF ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PT EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI