BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2960132 · Received February 13, 2013

    Report

    Report Number
    2122870-2013-00119
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    CEW
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS:SPINNER/GRIPPER FINGER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FAILING PARATHYROID HORMONE (PTH) AND PARATHYROID HORMONE - INTRAOPERATIVE (PTH-IO) QUALITY CONTROL (QC) AND CALIBRATIONS INVOLVING A UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM. WHILE TROUBLESHOOTING THE ISSUE WITH CUSTOMER TECHNICAL SUPPORT (CTS), A FAILED WASH PORTION OF SYSTEM CHECK WAS DISCOVERED THAT HAD BEEN GENERATED 2 HOURS PRIOR TO THE CALIBRATION AND QC ISSUES. THE CUSTOMER WAS UNAWARE OF THE FAILURE AND HAD CONTINUED TO OPERATE THE INSTRUMENT AND REPORT PATIENT RESULTS OUT OF THE LABORATORY. THE CUSTOMER WAS NO INFORMED OF ANY CHANGE OR DELAY IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CTS ADVISED THE CUSTOMER TO REPEAT THEIR SYSTEM CHECKS AGAIN WHICH FAILED TWICE. THE CUSTOMER INDICATED THAT ALL OTHER QC RESULTS HAD BEEN WITHIN RANGE BUT DATA WAS NOT SUPPLIED FOR REVIEW. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND THE SAMPLE PUMP BELT STRETCHED AND FRAYED. THE FSE REPLACED THE SAMPLE PUMP BELT AND A SUCCESSFUL PRESSURE SENSOR CALIBRATION WAS PERFORMED. THE ASPIRATE PROBE TUBING WAS ALSO REPLACED AND A SPINNER/GRIPPER FINGER WAS FOUND BROKEN. SERVICE WAS PERFORMED TO ADDRESS THE BROKEN SPINNER AND REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. THE LIKELY CAUSE OF THE EVENT WAS DETERMINED TO BE THE ASPIRATE PROBE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62382 UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE CEW BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1