BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAKO OMNIS

    MDR report key: 4528236 · Received February 13, 2015

    Report

    Report Number
    9610099-2015-00001
    Event Type
    Malfunction
    Date Received
    February 13, 2015
    Date of Event
    January 22, 2015
    Report Date
    February 9, 2015
    Manufacturer
    DAKO DENMARK A/S
    Product Code
    KPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP: AFTER DAKO'S ORIGINAL ROOT CAUSE INVESTIGATION INTO THE ORIGINAL OMNIS CONNECTIVITY ISSUE TO LIS-TRD, IT WAS CONCLUDED THAT THE LIS-TRD WAS WORKING AS INTENDED, BUT THAT THE INTERFACE TO THE OMNIS TRD SOFTWARE CONFIGURATION WAS NOT CLEARLY DEFINED. IT WAS CONCLUDED THAT THE INFORMATION PROVIDED TO THE CUSTOMERS IN THE DAKO OMNIS USER GUIDE WAS NOT CLEARLY COMMUNICATED. AFTER THE INITIAL INVESTIGATION WAS COMPLETED AND THE ROOT CAUSE IDENTIFIED, DAKO INITIATED A CLASS II RECALL. ALL AFFECTED CUSTOMERS WORLDWIDE HAVE BEEN CONTACTED AND 100 PERCENT ACKNOWLEDGEMENT REGARDING THE RECALL NOTIFICATION HAS BEEN DOCUMENTED AND ARCHIVED. THE PREVENTATIVE/CORRECTIVE ACTION OF UPDATING THE OMNIS USER GUIDE HAS BEEN COMPLETED AND APPROVED. THIS NEW INFORMATION WILL BE PROVIDED TO ALL CUSTOMERS WITH A SOFTWARE UPDATE DUE TO BE RELEASED APPROXIMATELY OCTOBER 2015. A SERVICE BULLETIN HAS BEEN PREPARED TO EDUCATE DAKO FIELD REPRESENTATIVES REGARDING THE DAKO OMNIS TRD CONFIGURATION. THIS SERVICE BULLETIN WILL HELP TO ENSURE THAT ALL NEW CUSTOMERS OF THE AFFECTED CONFIGURATION ARE INFORMED OF THE SITUATION. A REQUEST TO TERMINATE THE RECALL REGARDING THIS ISSUE HAS BEEN MADE TO FDA, AND THIS INVESTIGATION IS NOW CLOSED.

    Additional Manufacturer Narrative · 1

    THE PROCEDURE FOR HOW TO UPDATE SLIDES ALREADY SENT FROM THE LIS TO THE TRD WERE NOT EXPLAINED.

    Description of Event or Problem · 1

    OMNIS CONNECTIVITY TO LIS-TRD ISSUE: AN INCIDENT HAS BEEN REPORTED, FROM A CUSTOMER IN (B)(6), RELATED TO THE USE OF THE DAKO OMNIS SYSTEM WHEN UPDATING A TEST REQUEST FROM THE LABORATORY INFORMATION SYSTEM (LIS). THE INCIDENT OCCURRED WHEN THE CUSTOMER UPDATED AND PRINTED A SLIDE LABEL FROM THE LIS. WHEN A PATHOLOGIST REQUESTS SLIDES FROM THE LIS, AND SUBSEQUENTLY UPDATES A REQUEST BY CHANGING THE TEST, THIS UPDATE IS REJECTED BY THE OMNIS SOFTWARE MODULE, KNOWN AS THE TRD. DUE TO THIS REJECTION, THE LIS AND SLIDE LABEL PRINTED FROM THE LIS SYSTEM DISPLAY THE UPDATED TEST, INCLUDING THE REQUESTED CHANGE, BUT THE OMNIS SYSTEM WILL EXECUTE THE INITIAL TEST, NOT REFLECTING THE CHANGE MADE. THE ISSUE WAS VISUALLY DISCOVERED BY THE CUSTOMER DURING THEIR QUALITY CONTROL REVIEW AS THE EXPECTED TEST RESULTS DIFFERED FROM THE EXPECTED STAINING PATTERN. TO OUR KNOWLEDGE, NO PATIENT RESULTS HAVE BEEN AFFECTED AT THIS TIME. IF THE CUSTOMER ORDERS AND PRINTS THE SLIDE LABEL FROM THE DAKO OMNIS SYSTEM, THE TESTS ARE EXECUTED PROPERLY. WE HAVE IDENTIFIED THAT TWO OMNIS SYSTEMS WITH A TRD/LIS (OR TPID) CONFIGURATION ARE LOCATED IN THE USA. THE ROOT CAUSE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108366 DAKO OMNIS AUTOMATED SLIDE STAINER KPA DAKO DENMARK A/S GI100

    Patients

    Seq Age Sex Outcome Treatment
    1