BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 2080833 · Received May 6, 2011

    Report

    Report Number
    2122870-2011-01259
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    March 9, 2011
    Report Date
    April 4, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER COLLECTS BHCG SAMPLES IN EITHER PLASMA OR SERUM TUBES WITH A GEL SEPARATOR. CENTRIFUGATION INFORMATION HAS NOT BEEN SUPPLIED TO DATE. QC HAS BEEN WITHIN CUSTOMER'S ESTABLISHED RANGES. SPECIFIC QC DATA HAS NOT BEEN SUPPLIED TO DATE. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT WITH THE DATA PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT OBTAINING FALSE POSITIVE BHCG RESULTS FOR FOURTEEN (14) PATIENTS. THE RESULTS WERE GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. SUBSEQUENT TESTING AFTER RE-CENTRIFUGATION PRODUCED LOWER RESULTS IN A DIFFERENT GESTATIONAL CATEGORY. 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 ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER DHA BECKMAN COULTER INC. DXI 800

    Patients

    Seq Age Sex Outcome Treatment
    1