BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 3119535 · Received May 19, 2013

    Report

    Report Number
    2122870-2013-00474
    Event Type
    Malfunction
    Date Received
    May 19, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 19, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THE SPINNER GRIPPER (COLLET) FOR DISPENSE PROBE #3 WAS MISSING THREE COLLET FINGERS. THE FSE REMOVED THE WASH CAROUSEL AND NOTED THAT IT WAS NOT SEATED PROPERLY AND UNSTABLE. THE FSE DISCOVERED THE OTHER TWO COLLET FINGERS AND CLEANED THE WASH CAROUSEL OF DEBRIS. IN ADDITION, THE FSE INSTALLED NEW STYLE SPINNER GRIPPERS (COLLETS) PER SYSTEM MODIFICATION UPGRADE. THE FSE INSPECTED ALL OF THE RED PULLEYS FOR EXCESSIVE WEAR FROM THE WASH CAROUSEL; NONE WAS NOTED. THE FSE PERFORMED ALL NECESSARY ALIGNMENTS AND ADJUSTMENTS, PRIMED THE INSTRUMENT AND PERFORMED ROUTE 1 EXERCISER VERIFICATION; NO SYSTEM ERRORS WERE NOTED. THE FSE PERFORMED ANOTHER ROUTINE SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. A CARRYOVER TEST WAS ALSO PERFORMED WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. HIGH SENSITIVITY SYSTEM CHECK ALSO PASSED WITHIN INSTRUMENT SPECIFICATIONS. ASSAY CALIBRATION AND QUALITY CONTROL (QC) WERE PERFORMED AND EXHIBITED GOOD PRECISION. QC PASSED WITHIN THE LABORATORY'S ESTABLISHED RANGES. 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. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 2122870-2013-00471, 2122870-2013-00472, 2122870-2013-00473, 2122870-2013-00474, 2122870-2013-00475.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CARCINOEMBRYONIC ANTIGEN (CEA) QUALITY CONTROL (QC) IMPRECISIONS. DURING AN ONSITE VISIT, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) ALSO DISCOVERED ERRONEOUS VITAMIN B12, CORTISOL, HYB-PSA, TOTAL TRIIODOTHYRONINE (TT3) AND THYROID-STIMULATING HORMONE (TSH) RESULTS, FOR MULTIPLE PATIENTS, ON SEPARATE DAYS, INVOLVING THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM USED IN CONJUNCTION WITH THE ACCESS VITAMIN B12 ASSAY, ACCESS CORTISOL, ACCESS HYPERSENSITIVE HTSH, ACCESS TOTAL T3, AND ACCESS HYBRITECH PSA REAGENT. SUBSEQUENT ANALYSES OF 728 PATIENT SAMPLES CONFIRMED A TOTAL OF 11 DISCREPANT RESULTS, WHICH WERE RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE FSE ALSO NOTED THERE WERE IMPRECISIONS ON THE WASH PORTION OF SYSTEM CHECK. THE FIELD SERVICE ENGINEER (FSE) ASSESSED THE INSTRUMENT AT THE FACILITY. THIS IS REPORT THREE OF FIVE REFERENCING THE EVENT DATE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221061 UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1