BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1883595 · Received October 26, 2010

    Report

    Report Number
    2122870-2010-00664
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    August 31, 2010
    Report Date
    October 26, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COLLECTION TUBES FROM THE ER ARRIVE THOROUGH THE PNEUMATIC TUBE SYSTEM AND ARE PROCESSED ON THE AUTOMATION LINE. (SAMPLES 1/1, 2/1, 3/1, 5/1 AND 6/1 ARE FROM THE ER). QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THIS EVENT. SERVICE WAS NOT DISPATCHED FORT HIS EVENT. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING FALSE POSITIVE TOTAL BHCG (TBHCG) RESULTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR SEVEN DIFFERENT PATIENTS' SAMPLES. UPON REPEAT THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THE LOWER TBHCG RESULTS BETTER MATCHED THE PATIENTS' CLINICAL PICTURE AND WERE REPORTED OUT OF THE LAB. THE FALSE HIGH RESULTS WERE NOT REPORTED OUT OF THE LAB. 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 CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1