BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 1964377 · Received January 19, 2011

    Report

    Report Number
    2122870-2011-00075
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    November 29, 2010
    Report Date
    December 21, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A GREINER LITHIUM HEPARIN PLASMA TUBE. THE CUSTOMER CENTRIFUGES SAMPLES FOR 15 MINUTES AT 2200 RPM. HOWEVER, SOME SAMPLES ARE CENTRIFUGED FOR 6 MINUTES AT 2000 RPM. QC HAS BEEN WITHIN THE ESTABLISHED RANGES. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER IS NOT QUESTIONING INSTRUMENT PERFORMANCE AT THIS TIME. A CLEAR ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRATIC TOTAL BETA HCG (TBHCG) RESULTS IN DIFFERENT GESTATIONAL AGE CATEGORIES GENERATED BY UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER FOR ONE PATIENT. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED REPRODUCIBLE RESULTS. 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 JJE BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1