BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI® 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 3191876 · Received June 27, 2013

    Report

    Report Number
    2122870-2013-00574
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER CTS (CUSTOMER TECHNICAL SUPPORT) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE PHONE AND ADVISED THE CUSTOMER TO PERFORM A SYSTEM CHECK. THE CUSTOMER STATED THAT THE SYSTEM CHECK FAILED THE WASH PORTION WITH A %CV (COEFFICIENT OF VARIATION) OF 156.17% AS COMPARED TO A SPECIFICATION OF LESS THAN 12%. THE CTS INSTRUCTED THE CUSTOMER TO NOT USE THE INSTRUMENT AND DISPATCHED AN FSE (FIELD SERVICE ENGINEER) TO EVALUATE THE INSTRUMENT. THE FSE DETERMINED THAT THE INSTRUMENT'S ASPIRATE PROBES AND PERI-PUMP TUBING REQUIRED REPLACEMENT AND PROCEEDED TO REPLACE THE IDENTIFIED PARTS. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. FAILURE MODE IS ATTRIBUTED TO THE ASPIRATE PROBES AND PERI-PUMP TUBING WHICH REQUIRED REPLACEMENT TO ACHIEVE PASSING QC AND SYSTEM CHECK. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING FAILING ACCESS AFP (ALPHA-FETOPROTEIN) CALIBRATIONS, DUE TO A BAD CALIBRATION CURVE FIT, INVOLVING THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. IN ADDITION, THE CUSTOMER INDICATED THAT MULTIPLE ASSAYS FAILED QC. THE CUSTOMER IS UNAWARE OF ANY ERRONEOUS PATIENT RESULTS GENERATED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292786 UNICEL DXI® 800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1