BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2060339 · Received April 16, 2011

    Report

    Report Number
    2122870-2011-00962
    Event Type
    Malfunction
    Date Received
    April 16, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE COLLECTED IN A BD SERUM SEPARATOR TUBE. QC HAS BEEN PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE 03/16/2011. FSE CHECKED FLUID CONNECTIONS, CALIBRATED ULTRASONIC VOLTAGES AND CLEANED SALT FROM THE SUBSTRATE PRIMER. FSE PERFORMED A SYSTEM CHECK AND A HIGH-SENSITIVITY SYSTEM CHECK AND BOTH PASSED WITHIN INSTRUMENT SPECIFICATIONS. FSE VERIFIED THE SERVICE FOLLOWING ESTABLISHED PROCEDURES AND ALL RESULTS WERE WITHIN INSTRUMENT SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A HIGHER THAN EXPECTED BHCG RESULT ABOVE THE NORMAL REFERENCE RANGE GENERATED BY THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. REPEAT ANALYSIS OF THE SAMPLE GAVE LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE "LOW RESULT" WAS REPORTED OUTSIDE OF THE LABORATORY AND WAS NOT QUESTIONED BY THE PHYSICIAN. THE CUSTOMER'S PROTOCOL IS TO RUN ALL BHCG REQUESTS WITH THE DIL-BHCG ASSAY TO REDUCE OVERALL REPORTING TIME. THE ORIGINAL TBHCG RESULT WAS 0.3MIU/ML AND THE ORIGINAL DIL-TBHCG RESULT WAS 2481.8MIU/ML. THE REPEAT TBHCG RESULTS WERE 0.8 AND 0.5MIU/ML AND THE REPEAT DIL-TBHCG RESULTS WERE <1000 MIU/ML. 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® DXL 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXI 800 015305, 014414

    Patients

    Seq Age Sex Outcome Treatment
    1