BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1884338 · Received October 27, 2010

    Report

    Report Number
    2122870-2010-00663
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BHCG SAMPLES WERE COLLECTED IN BOTH LITHIUM HEPARIN PLASMA TUBES AND SERUM TUBES. THE SYSTEM IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS. A ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(6) 2010 AND PASSED WITHIN INSTRUMENT'S SPECIFICATIONS. SERVICE WAS NOT DISPATCHED FOR THIS 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 IN., (BCI) REGARDING FALSE POSITIVE TOTAL BHCG (TBHCG) RESULTS ABOVE THE NORMAL REFERENCE RANGE GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. SUBSEQUENT TESTING ON AN ALTERNATE ANALYZER PRODUCED A LOWER RESULT WITHIN THE NORMAL REFERENCE RANGE. THE RESULTS WERE 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 DHA BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1