BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 3031788 · Received April 2, 2013

    Report

    Report Number
    2122870-2013-00337
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Removal / Correction Number
    Z-1736-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) NOTED THE SAMPLE PROBE CARRY-OVER TEST FAILED AND INSTALLED A NEW SAMPLE PROBE AND CARRY-OVER TEST PASSED. THE FSE COMPLETED HIGH SENSITIVITY SYSTEM CHECK WITH PASSING RESULTS. QUALITY CONTROL (QC) WAS WITHIN THE LABORATORY'S ESTABLISHED LIMITS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. THE PATIENT'S SAMPLES WERE COLLECTED IN A 13X100 MM GREEN TOP TUBE AND CENTRIFUGED AT 3,000 RPM (ROTATIONS PER MINUTE) FOR SEVEN MINUTES. THE SAMPLES WERE ANALYZED ON THE DAY OF COLLECTION AND REFRIGERATED AFTER THE ANALYSIS. SAMPLE QUALITY APPEARED NORMAL. THE LABORATORY PERFORMS QUALITY CONTROL (QC) EVERY EIGHT HOURS. QC WAS WITHIN RANGE AT THE TIME OF THE EVENT. THE CUSTOMER REANALYZED RECENT AND ANY NEW POSITIVE RESULTS FOR ACCURACY VERIFICATION. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2013-00338.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS BETA HUMAN CHORIONIC GONADOTROPHIN (HCG) RESULTS, FOR TWO PATIENTS, ON TWO SEPARATE DAYS, INVOLVING THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM UTILIZED WITH THE ACCESS® TOTAL SSHCG ASSAY AND CALIBRATORS. SUBSEQUENT ANALYSES OF THE PATIENTS' SAMPLES, ON AN ALTERNATE UNICEL DXI 800 SYSTEM, RECOVERED LOWER RESULTS. A SECOND SAMPLE WAS COLLECTED EIGHT HOURS AFTER AND ALSO PRODUCED A LOWER RESULT. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THE CUSTOMER COULD NOT CONFIRM IF THERE WAS ANY CHANGE TO PATIENT CARE. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE SAMPLE WAS INITIALLY TESTED FROM THE PRIMARY TUBE ON THE AUTOMATION LINE AND THE REANALYSIS WAS MANUALLY LOADED THROUGH THE SPECIMEN PROCESSING UNIT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THIS REPORT REFERENCES PATIENT ONE OF TWO FOR THE EVENT DATE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134562 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE DHA BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR