BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2202825 · Received August 11, 2011

    Report

    Report Number
    2122870-2011-02882
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 17, 2011
    Report Date
    July 12, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN SST TUBES. THE CENTRIFUGATION INFORMATION WAS NOT SUPPLIED. THE LAB PROTOCOL IS TO REPEAT TESTS ON ALL SAMPLES OF TBHCG RESULTS < 50MIU/ML. THE CUSTOMER IS MONITORING TBHCG FLIERS BY DOCUMENTING THE NON-REPRODUCIBLE RESULTS, SAMPLE TYPE, TUBE LOT NUMBERS AND WHAT CLINIC OR WARD THE SAMPLE WAS OBTAINED FROM. NO PATTERNS HAVE BEEN FOUND. THE CUSTOMER HAS BEEN OBSERVING LOWER RESULTS WHEN THE HCG HIGH FLIER SAMPLES ARE RE-SPUN AND RERUN. QC HAS BEEN WITHIN THE ESTABLISHED RANGES. NO HARDWARE ISSUES AND NO OTHER ASSAYS ARE BEING QUESTIONED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) CONCERNING A POSITIVE TOTAL BETA HUMAN CHORIONIC GONADOTROPIN (TBHCG) RESULT GENERATED BY UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. REPEAT TESTING AFTER RE-CENTRIFUGATION PRODUCED A NEGATIVE RESULT. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT 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 CLINICAL CHEMISTRY ANALYZER DHA BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1