BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2242301 · Received September 10, 2011

    Report

    Report Number
    2122870-2011-03400
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND PREPARATION INFORMATION WAS NOT PROVIDED. THE CUSTOMER STATED THAT THE INSTRUMENT WAS OPERATING WITHIN THE CUSTOMER'S QUALITY CONTROL SPECIFICATIONS. THE CUSTOMER SENT THE SAMPLE TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR FURTHER TESTING. RESULTS DEMONSTRATED THE PRESENCE OF HETEROPHILE INTERFENTS IN THE PATIENT'S SAMPLE. PER PRODUCT LABELING, "FOR ASSAYS EMPLOYING ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HETEROPHILE ANTIBODIES IN THE PATIENT SAMPLE. PATIENTS WHO HAVE BEEN REGULARLY EXPOSED TO ANIMALS OR HAVE RECEIVED IMMUNOTHERAPY OR DIAGNOSTIC PROCEDURES UTILIZING IMMUNOGLOBULINS OR IMMUNOGLOBULIN FRAGMENTS MAY PRODUCE ANTIBODIES, E.G. HAMA, THAT INTERFERE WITH IMMUNOASSAYS. ADDITIONALLY, OTHER HETEROPHILE ANTIBODIES SUCH AS HUMAN ANTI-GOAT ANTIBODIES MAY BE PRESENT IN PATIENT SAMPLES. SUCH INTERFERING ANTIBODIES MAY CAUSE ERRONEOUS RESULTS. CAREFULLY EVALUATE THE RESULTS OF PATIENTS SUSPECTED OF HAVING THESE ANTIBODIES."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING A REACTIVE HEPATITIS B SURFACE ANTIGEN (HBSAG) RESULT GENERATED ON A UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM USED IN CONJUNCTION WITH ACCESS HBSAG REAGENT (LOT 192335) FOR ONE (1) PATIENT. THIS RESULT WAS NOT CONFIRMED AND WAS DISCORDANT WITH THE RESULTS OBTAINED ON ALTERNATE METHODS. THE REACTIVE RESULT WAS NOT REPORTED OUT OF THE LAB. THERE ARE NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1