BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2040466 · Received April 5, 2011

    Report

    Report Number
    2122870-2011-00909
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    September 18, 2008
    Report Date
    September 18, 2008
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS PLASMA COLLECTED INTO A LITHIUM HEPARIN GEL TUBE AND CENTRIFUGED AT 2400 RPM FOR 10 MINUTES. PER CUSTOMER, ALL TESTING WAS RUN ON THE PRIMARY TUBES. QC ARE RUN DAILY AND CONFIRMED NO PERFORMANCE ISSUES BEEN NOTED. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED HIGH SENSITIVITY SYSTEM CHECK ACCUTNI VERIFICATION, WHICH PASSED. FSE INSTRUCTED THE CUSTOMER ON PROPER SAMPLE HANDLING PROCEDURES. FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. RESULTS MET PUBLISHED PERFORMANCE VERIFICATIONS. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FROM THE INFORMATION PROVIDED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS WITHIN THE DATE RANGE OF (B)(4) 2011 - (B)(4) 2011 FOR ADDITIONAL REPORTABLE EVENT/OCCURRENCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO NON REPRODUCIBLE ELEVATED ACCUTNI RESULT BELOW THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF, THE RISK STRATIFICATION RANGE GENERATED BY THE UNICEL DXI 800 IMMUNOASSAY ANALYZER. THE RESULT WAS REPORTED OUT OF THE LABORATORY AND QUESTIONED AFTER A SECOND DRAW RESULTS WITHIN THE REFERENCE RANGE. THE SAMPLE WAS REPEATED AND RESULT WITHIN THE REFERENCE RANGE WAS OBTAINED. THE PATIENT WAS ADMITTED TO THE HOSPITAL; HOWEVER NO INVASIVE TREATMENT WERE PERFORMED AS A RESULT OF THIS EVENT. THE CUSTOMER DID NOT REPORT ANY ISSUES OR CONCERNS IN REGARDS TO PATIENT OR USER ATTRIBUTED OR CONNECTED TO 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. DXI800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization