BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2342879 · Received November 18, 2011

    Report

    Report Number
    2122870-2011-05571
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Date of Event
    October 19, 2011
    Report Date
    October 20, 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
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE WAS COLLECTED IN A GREEN TOP PLASMA SEPARATOR TUBE AND CENTRIFUGED FOR 2 MINUTES AT 15000 RPM. PER THE CUSTOMER COMPLAINT RECORD, QC WAS NOT PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED LIMITS AT THE TIME OF THE EVENT. SERVICE HAS NOT BEEN DISPATCHED TO DATE FOR THIS EVENT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING A REPRODUCIBLE ELEVATED DIL - BETA HUMAN CHORIONIC GONADOTROPIN (DIL-BHCG) RESULT IN THE SAME GESTATIONAL CATEGORY THAT WAS BEING QUESTIONED BY THE CUSTOMER GENERATED BY THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER PROVIDED THE RESULTS THAT WERE QUESTIONED ORIGINALLY AND IT WAS DETERMINED THAT THE PATIENT RESULTS WERE GENERATED FROM AN ALTERNATE INSTRUMENT, WHICH WERE REPRODUCIBLE AND FELL WITHIN THE LABELED BHCG ASSAY PRECISION CLAIMS. THE RESULT GENERATED ON THE DXI 600 INSTRUMENT PRODUCED A RESULT IN THE SAME GESTATIONAL CATEGORY BUT THE RESULT DID NOT MEET LABELED ASSAY PRECISION CLAIMS WHEN PAIRED WITH THE RESULTS OBTAINED FROM THE CUSTOMER'S OTHER INSTRUMENT. 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 600 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE DHA BECKMAN COULTER INC. DXI 600 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1