BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 590398 · Received February 24, 2005

    Report

    Report Number
    2122870-2005-00021
    Event Type
    Other
    Date Received
    February 24, 2005
    Date of Event
    January 26, 2005
    Report Date
    February 23, 2005
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER INFORMED A BECKMAN COULTER FIELD REPRESENTATIVE REGARDING A FALSELY LOW BHCG TEST RESULT ON A SINGLE PATIENT THAT WAS GENERATED BY THE UNICEL DXI INSTRUEMENT. THE FALSELY LOW BHCG RESULT FROM SAMPLE A WAS 0.01MLU/ML. THE LOW BHCG WAS REPORTED OUT OF THE LAB. THE CUSTOMER INDICATED THAT AFTER ABOUT A WEEK, THE PHYSICIAN REQUESTED A NEW SAMPLE TO BE COLLECTED FROM THE SAME PATIENT AND TESTED FOR BHCG. THE BHCG RESULT FROM SAMPLE B WAS 78,298MLU/ML. BASED ON THE ELEVATED BHCG RESULT FROM SAMPLE B, THE CUSTOMER RETESTED SAMPLE A. THE REPEATED BHCG RESULT FROM SAMPLE A WAS 71,926MLU/ML. THE BHCG RESULTS FROM SAMPLE B AND THE REPEATED RESULT FROM SAMPLE A WERE IN THE 5-8 WEEKS GESTATINAL AGE ACCORDING TO THE GESTATIONAL AGE CHART IN THE ASSAY GUIDE. NO ADDITIONAL EVENT INFORMATION WAS PROVIDED BY THE CUSTOMER. THERE HAS BEEN NO CHANGE TO PATIENT TREATMENT OR ANU INJURY THAT CAN BE ATTRIBUTED 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 JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other