BEUDAMED
    FDA Adverse Event Summary report: N

    DAKO OMNIS

    MDR report key: 5514660 · Received March 21, 2016

    Report

    Report Number
    9610099-2016-00001
    Date Received
    March 21, 2016
    Date of Event
    February 19, 2016
    Report Date
    November 11, 2016
    Manufacturer
    DAKO DENMARK A/S
    Product Code
    KPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DAKO ATTEMPTED TO SUBMIT THIS MDR ON MARCH 18, 2016 BUT DUE TO THE ACCOUNT BEING LOCKED AND WHILE WORKING WITH THE ESG HELP DESK TO RESOLVE THIS ISSUE, WE WERE UNABLE TO SUBMIT THE MDR ON TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP: INVESTIGATION: BASED ON THE INVESTIGATION, WE BELIEVE THAT THE ISSUE IS DUE TO USER ERROR (POSSIBLE ROOT CAUSE). DAKO HAS TRIED TO RECEIVE THE RELEVANT DAKO OMNIS LOG FILES, BUT THIS HAS NOT BEEN POSSIBLE. THERE HAS BEEN A CLOSE DIALOGUE WITH THE CUSTOMER AND AN ACTION PLAN HAS BEEN AGREED UPON: NEW DAKO OMNIS UNIT IS INSTALLED. ASSESSMENT OF DETECTABILITY: IT HAS BEEN ASSESSED THAT DETECTABILITY OF WEAK OR NO STAINING WOULD BE HIGH (DETECTABILITY SCORE OF 2) SINCE THE IFUS OF ALL DAKO ANTIBODIES FOR AUTOMATED STAINING PLATFORMS AS WELL AS STANDARD LABORATORY PRACTICES RECOMMEND THE USE OF APPROPRIATE STAINING CONTROLS AND THAT THE CLINICAL INTERPRETATION OF ANY STAINING OR ITS ABSENCE SHOULD BE EVALUATED WITHIN THE CONTEXT OF THE PATIENT'S CLINICAL HISTORY BY A QUALIFIED PATHOLOGIST. CONCLUSION: DAKO CONSIDERS THIS AS AN ISOLATED INCIDENT, AS ONLY THIS CUSTOMER HAS HAD THIS ISSUE. DAKO HAS ASSESSED NO PATIENT RISK ASSOCIATED TO THE REPORTED INCIDENT. NEW DAKO OMNIS UNIT WAS INSTALLED. THIS INVESTIGATION IS CLOSED.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES COMPLAINED ABOUT INCONSISTENT STAINING ON THE DAKO OMNIS INSTRUMENT WHICH MAY HAVE CONTRIBUTED TO AN INCORRECT PATIENT DIAGNOSIS AND INCORRECT TREATMENT. THE CUSTOMER USED A WILMS' TUMOR 1 (WT1) PROTEIN ANTIBODY ON THE DAKO OMNIS INSTRUMENT. DAKO DOES NOT MARKET A WT1 READY-TO-USE ANTIBODY FOR THE DAKO OMNIS AND THE WT1 ANTIBODY IS THEREFORE NOT VALIDATED FOR THE DAKO OMNIS. THE COMPLAINT IS STILL UNDER INVESTIGATION AND DAKO DOES NOT CURRENTLY KNOW IF THE ANTIBODY USED WAS PRODUCED BY DAKO. THE WT1 PROTEIN ANTIBODY WAS USED TO HELP DIFFERENTIATE A MALIGNANT SMALL CELL CARCINOMA FROM A BENIGN CARCINOID. THE CUSTOMER INDICATED THAT A POSITIVE CONTROL TISSUE FOR WT1 WAS RUN WITH THE PATIENT BIOPSY AND THAT BOTH TISSUE SECTIONS SHOWED LITTLE OR NO STAINING. BOTH WERE CONSIDERED NEGATIVE. ALTHOUGH THE POSITIVE CONTROL SLIDE WAS NEGATIVE AND THE TEST RESULT THEREFORE SHOULD HAVE BEEN CONSIDERED INVALID PER STANDARD PRACTICE, THE PATHOLOGIST EXAMINED THE MORPHOLOGY OF THE PATIENT TISSUE AND IDENTIFIED THE LESION AS MALIGNANT. THE LESION SUBSEQUENTLY WAS REMOVED. TESTING OF THE RESECTED MATERIAL WITH WT1 WAS DETERMINED POSITIVE BY THE CUSTOMER. ADDITIONAL REVIEW OF THE BIOPSY STAINING DETECTED A LOW LEVEL OF POSITIVE STAINING, BUT THE DETAILS OF THIS ADDITIONAL TESTING (ANTIBODY AND INSTRUMENT USED) ARE NOT AVAILABLE AT THIS TIME. THE DAKO OMNIS USER GUIDE STATES THAT: "THE CLINICAL INTERPRETATION OF ANY POSITIVE STAINING OR ITS ABSENCE SHOULD BE COMPLEMENTED BY MORPHOLOGICAL AND HISTOLOGICAL STUDIES WITH PROPER CONTROLS. EVALUATIONS SHOULD BE MADE WITHIN THE CONTEXT OF THE PATIENT'S CLINICAL HISTORY AND OTHER DIAGNOSTIC TESTS. IT IS THE RESPONSIBILITY OF A QUALIFIED PATHOLOGIST WHO IS FAMILIAR WITH THE ANTIBODIES, REAGENTS AND METHODS USED TO INTERPRET THE STAINED PREPARATION." IN ADDITION, IF THE CUSTOMER USED A DAKO ANTIBODY, THE DAKO IFU RECOMMENDS THAT "POSITIVE AND NEGATIVE CONTROLS SHOULD BE RUN SIMULTANEOUSLY WITH PATIENT SPECIMENS." THE INVESTIGATION IS ONGOING TO DETERMINE THE ROOT CAUSE. DAKO HAS NOT VALIDATED WT1 ON THE OMNIS AND THEREFORE DOES NOT FULLY UNDERSTAND THE PERFORMANCE.

    Description of Event or Problem · 1

    PLEASE SEE ADDITIONAL MANUFACTURER NARRATIVE SECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169880 DAKO OMNIS DAKO OMNIS KPA DAKO DENMARK A/S GI100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other