BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM.

    MDR report key: 1874298 · Received October 19, 2010

    Report

    Report Number
    2122870-2010-00630
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 19, 2010
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE ERRONEOUS RESULTS. THE CUSTOMER REANALYZED SERUM AND PLASMA ON KNOWN PREGNANT AND NON PREGNANT FEMALE SAMPLES ON BOTH INSTRUMENTS. ALL SAMPLE RESULTS WERE REPRODUCIBLE AND NO RESULT DIFFERENCE BETWEEN THE PLASMA AND SERUM WAS SEEN. THE PHYSICIAN BELIEVES THE LOWER TBHCG RESULTS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE SAMPLE PROBE. NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO OBTAINING FALSE POSITIVE BETA - HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULTS FROM ONE PATIENT'S SERUM SAMPLE THAT WAS DISCREPANT TO THE SAME PATIENT'S PLASMA SAMPLE DRAWN AT THE SAME TIME THAT WAS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. BOTH SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT AND PRODUCED THE SAME DISCREPANCY. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED 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 JJE BECKMAN COULTER INC. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1