BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1994078 · Received February 16, 2011

    Report

    Report Number
    2122870-2011-00381
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 2, 2011
    Report Date
    January 19, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A SST TUBE. THE SPECIMEN WAS ALLOWED TO CLOT FOR 3 HOURS. THE SAMPLE WAS SPUN AT 3,500G FOR 7 MINUTES. IT WAS NOTED THAT THE SAMPLE WAS CLEAR AND HAD NO VISIBLE CELLULAR DEBRIS. THE SPECIMEN WAS ANALYZED 2 HOURS POST CENTRIFUGATION. THE CUSTOMER RUNS QC EVERY 40 SAMPLES. QC WAS WITHIN RANGE AT THE TIME OF EVENT. THE LAB RUNS THE SPECIAL CLEAN TWICE A DAY, PIPETTOR MATCHING IS PERFORMED EVERY TWO WEEKS, THE PROBES ARE REPLACED AND A SYSTEM CHECK IS RUN WEEKLY. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND CHECKED PIPETTOR ALIGNMENTS AND PERFORMED A DIAGNOSTIC TESTING. NO HARDWARE ISSUES WERE IDENTIFIED. NO ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING OBTAINING A FALSE POSITIVE TOTAL BHCG (TBHCG) RESULT THAT WAS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LAB AND WAS QUESTIONED BY THE CLINICIAN. SUBSEQUENT TESTING PRODUCED A NEGATIVE RESULT. 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 DHA BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR