BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 3405533 · Received October 11, 2013

    Report

    Report Number
    2122870-2013-00815
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    June 7, 2013
    Report Date
    September 13, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER UPLOADED A NEW ASSAY PROTOCOL FILE (APF) ONTO THE CUSTOMER'S DXI INSTRUMENT TO RESOLVE THE ISSUE. THE FLYERS OBTAINED BY THE CUSTOMER WERE LIKELY DUE TO MISALIGNED PIPETTORS, AND THE NEW APF VERSION OF THE GI MONITOR WHICH WAS UPLOADED ONTO THE CUSTOMER'S DXI MIGHT HAVE RESOLVED THE ISSUE. THE CUSTOMER HAS NOT REPORTED A RECURRENCE OF THIS ISSUE AS OF (B)(4) 2013. ALL ASSOCIATED MEDWATCH REPORTS RELATED TO THIS EVENT: 2122870-2013-00815; 2122870-2013-00837; 2122870-2013-00838; 2122870-2013-00839; 2122870-2013-00840; 2122870-2013-00841; 2122870-2013-00847; 2122870-2013-00848; 2122870-2013-00849; 2122870-2013-00850. DEVICE EVAL: DATA ANALYSIS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ACCESS GASTROINTESTINAL (GI) MONITOR FLYERS, FOR MULTIPLE PATIENT AND QUALITY CONTROL (QC) SAMPLES, OVER SEVERAL DAYS, INVOLVING THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER PROVIDED DATA FOR ANALYSIS AND BECKMAN COULTER NOTED SEVERAL GI MONITOR QC FLYERS WHICH WERE FLAGGED WITH QCF FLAGS, INDICATING THAT THE RESULTS VIOLATED ONE OR MORE QC RULES. AN ANALYSIS OF THE DATA INDICATED THAT FLYERS WERE OBTAINED ON MULTIPLE GI MONITOR REAGENT PACK LOT NUMBERS AND ON VARIOUS REAGENT PACK POSITIONS. THE FLYERS WERE OBSERVED WITH THREE PIPETTORS BUT MAINLY WITH PIPETTOR #3. BECKMAN COULTER NOTED THAT THIS ISSUE IS SIMILAR TO ISSUES ENCOUNTERED WITH MISALIGNED PIPETTORS. THE CUSTOMER HAS PROVIDED MULTIPLE PATIENT SAMPLE RESULTS ASSOCIATED WITH THIS EVENT. THE PATIENT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THIS REPORT REFERENCES THE EVENT WHICH OCCURRED ON (B)(6) 2013. ACCESS GI MONITOR REAGENT PART NUMBER 387687 WAS USED IN CONJUNCTION WITH THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524499 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