BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2866714 · Received December 10, 2012

    Report

    Report Number
    2122870-2012-01985
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 12, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) PERFORMED SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK, WHICH PASSED WITHIN SPECIFICATION FOR ALL PARAMETERS. THE FSE VERIFIED TOTAL BETA HUMAN CHORIONIC GONADOTROPHIN (TBHCG) PRECISION WAS WITHIN SPECIFICATION AND QUALITY CONTROL (QC) WAS WITHIN THE LABORATORY'S ESTABLISHED LIMITS. NO HARDWARE ISSUES WERE IDENTIFIED. THE UNIT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. A DEFINITIVE CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT TOTAL BETA HUMAN CHORIONIC GONADOTROPHIN (TBHCG) RESULTS, FOR ONE PATIENT, INVOLVING THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE DISCREPANT RESULTS WERE RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. COMPUTED TOMOGRAPHY (CT) SCAN WAS DELAYED FOR APPROXIMATELY FIVE HOURS DUE TO THE DISCREPANT RESULTS. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME TO DATE. THE CUSTOMER STATED BHCG QUALITY CONTROL (QC) HAD BEEN WITHIN SPECIFICATIONS. THE PATIENT SAMPLES WERE COLLECTED INTO A BECTON DICKINSON (BD) TOP VACUTAINER TUBE WITH GEL BARRIER. THE SAMPLES WERE CENTRIFUGED AT 3,000 RPM (ROTATIONS PER MINUTE) FOR SEVEN MINUTES, AT ROOM TEMPERATURE. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE DHA BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other