BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 600 SYNCHRON CHEMISTRY ANALYZER

    MDR report key: 2060440 · Received April 17, 2011

    Report

    Report Number
    2122870-2011-01017
    Event Type
    Malfunction
    Date Received
    April 17, 2011
    Date of Event
    December 15, 2010
    Report Date
    March 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A 13X100MM SERUM TUBE WITH A GEL SEPARATOR. THE SAMPLE WAS CENTRIFUGED FOR TEN MINUTES AT 2500 RPM. PER CUSTOMER, THE SAMPLES ARE ANALYZED FROM THE PRIMARY TUBE THROUGH THE CLOSE TUBE ACCESSION. QC AND SYSTEM INFORMATION HAS NOT BEEN SUPPLIED TO DATE. SERVICE WAS NOT DISPATCHED. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT WITH THE DATA PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT HIGHER THAN EXPECTED HYB-PSA RESULT ABOVE THE NORMAL REFERENCE RANGE FOR ONE PATIENT GENERATED BY UNICEL DXI 600 ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULT WAS REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN NEW SAMPLE WAS RUN ON THE SAMPLE UNIT AND LOWER RESULT WAS OBTAINED, WHICH BETTER REPRESENTED THE PATIENT'S CLINICAL HISTORY. UNKNOWN IF PATIENT TREATMENT WAS IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 600 SYNCHRON CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXI 600 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1