BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2040145 · Received April 5, 2011

    Report

    Report Number
    2122870-2011-00905
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    July 27, 2008
    Report Date
    July 29, 2008
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS COLLECTED AS SERUM IN RED TOP TUBES WITH GEL SEPARATOR. CENTRIFUGATION INFORMATION NOT SUPPLIED. QC WAS IN RANGE. CUSTOMER STATED THAT FIBRIN WAS FOUND IN SAMPLE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. SERVICE DISCUSSED, VIA TELEPHONE, EXTENSIVELY PRE-ANALYTICAL SAMPLE HANDLING ISSUES WITH CUSTOMER. THE CUSTOMER STATED THAT THE "ASPIRATION MONITOR DETECT" ERRORS WERE GENERATED AT ABOUT THE SAME TIME THAT THE SAMPLE WAS BEING ASPIRATED. PRE-ANALYTICAL SAMPLE HANDLING IS THE ROOT CAUSE FOR THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS WITHIN THE DATE RANGE OF (B)(4) 2010 - (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) IN REGARDS TO OBTAINING AN ERRONEOUSLY HIGH ACCUTNI RESULT ON ONE (1) PATIENT, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF THAT WAS REPORTED OUT OF THE LABORATORY, GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. SUBSEQUENT TESTING PRODUCED A NORMAL RESULT. THE DOCTOR QUESTIONED THE INITIAL HIGH RESULT, WHICH UPON RERUN WAS IN THE RISK STRATIFICATION RANGE. A CORRECTED REPORT WAS ISSUED. IT IS UNKNOWN WHETHER PATIENT TREATMENT WAS AFFECTED IN 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. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1