BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2032564 · Received March 29, 2011

    Report

    Report Number
    2122870-2011-00864
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    July 2, 2008
    Report Date
    July 2, 2008
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS COLLECTED IN A BD LI HEPARIN PLASMA TUBE WITH A GEL SEPARATOR AND PROCESSED ON THEIR AUTOMATION LINE. QC DATA WAS NOT SUPPLIED. SYSTEM CHECK DATA WAS NOT SUPPLIED SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE CUSTOMER STATED THAT THIS ISSUE IS SAMPLE RELATED AND INSTRUMENT PERFORMANCE WAS NOT IN QUESTION. CUSTOMER TECHNICAL SUPPORT (CTS) REQUESTED SAMPLE FROM THE ER PATIENT FOR HETEROPHILE TESTING, BUT CUSTOMER DID NOT HAVE ANY SAMPLES TO SEND TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) AT THAT TIME FOR THIS EVENT. ALTHOUGH HETEROPHILE INTERFERENCE IS A LIKELY CONTRIBUTOR, A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS WITHIN THE DATE RANGE OF (B)(6) 2010 - (B)(6) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) IN REGARDS TO OBTAINING ELEVATED TROPONIN (ACCUTNI) RESULTS, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF ON FOR ONE (1) PATIENT OVER MULTIPLE DRAWS, GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE RESULTS WERE REPRODUCIBLE AND WERE DISCORDANT TO AN ALTERNATE METHODOLOGY. PATIENT WAS ADMITTED TO THE HOSPITAL FROM THE ER FOR OBSERVATION OF POSSIBLE CARDIAC SYMPTOMS. THE CUSTOMER WAS NOT MADE AWARE OF CHANGE IN TREATMENT WHICH OCCURRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization