BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2771231 · Received October 3, 2012

    Report

    Report Number
    2122870-2012-01789
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 10, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THE SEALS ON THE PRECISION PUMP WERE NOT TIGHT. THE FSE REBUILT THE PRECISION PUMP, REPLACED THE BELT, CLIP, STACK SPRING, AND INSTALLED NEW SEALS. THE FSE PERFORMED A PRECISION TEST, HIGH SENSITIVITY SYSTEM CHECK, CARRYOVER TEST, DIL-TEST, AND PIPETTOR VERIFICATION; ALL RESULTS WERE WITHIN THE ASSAY, INSTRUMENT, AND LABORATORY SPECIFICATIONS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. RESULTS CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. THE CUSTOMER-SUPPLIED DATA INDICATES SYSTEM PARAMETERS (INCLUDING QUALITY CONTROL (QC) AND CALIBRATION) PERFORMED WITHIN THE ASSAY AND INSTRUMENT SPECIFICATIONS AT THE TIME OF THE EVENT. A ROUTINE SYSTEM CHECK, PERFORMED ON (B)(4) 2012, SHOWS A FAILING UNWASHED PORTION OF THE SYSTEM CHECK WITH A HIGH PERCENT COEFFICIENT OF VARIATION (%CV. THE CUSTOMER REPEATED SYSTEM CHECK AND WAS ABLE TO OBTAIN A PASSING RESULT. THE CUSTOMER INDICATED THE SAMPLES WERE COLLECTED INTO RED TOP SERUM TUBES AND WERE CENTRIFUGED AT 2,000 RPM (REVOLUTIONS PER MINUTE) FOR TEN MINUTES AT 4°C. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2012-01788.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED IMPRECISE DIL-HCG (HUMAN CHORIONIC GONADOTROPIN) RESULTS, OUTSIDE THE PRECISION CLAIMS OF THE ASSAY, FOR MULTIPLE PATIENTS, ON SEPARATE DAYS INVOLVING THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM. THIS IS REPORT TWO OF TWO. AN ALIQUOT OF THE PATIENT SERUM SAMPLE WAS CHECKED FOR INTEGRITY, RE-CENTRIFUGED, AND REANALYZED. THE CUSTOMER CURRENTLY PERFORMS ALL DIL-HCG TESTING IN DUPLICATE AND EVALUATES THE RESULTS AGAINST A 15% PRECISION CLAIM CRITERIA SET IN THE LABORATORY. THE DISCREPANT RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. 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 600 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE DHA BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1