BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTANA ALK (D5F3) CDX ASSAY

    MDR report key: 19012697 · Received April 1, 2024

    Report

    Report Number
    2028492-2024-00978
    Event Type
    Malfunction
    Date Received
    April 1, 2024
    Date of Event
    March 5, 2024
    Report Date
    April 16, 2024
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC.
    Product Code
    PKW
    PMA / PMN Number
    P140025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE BENCHMARK ULTRA STAINER MODULE IS (B)(6). THE FIELD APPLICATION SPECIALIST VISITED THE SITE AND FOUND THAT THE CUSTOMER'S VORTEX MIXERS WERE ALL OUTSIDE OF SPECIFICATIONS. THE SPECIALIST NOTED THAT THE INSTRUMENT REAGENT DISPENSE VOLUME FOR IMMUNOHISTOCHEMISTRY (IHC) TESTS WAS TOO LOW AND THAT THE REAGENT DISPENSE VOLUME FOR IN-SITU HYBRIDIZATION (ISH) TESTS WAS TOO HIGH. ALK (D5F3) IS AN IHC TEST. THE SPECIALIST CORRECTED THESE ISSUES. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPEATED THE ALK (D5F3) STAINING OF THE SAMPLE TWICE. THE FIRST REPEAT WAS COMPLETELY NEGATIVE, FREE OF STAIN. THE SECOND REPEAT HAD SOME NON-SPECIFIC LIGHT BLUSHING BUT WAS CLEARLY DIAGNOSABLE AS NEGATIVE. THE CUSTOMER STATED THAT A THIRD PARTY HAD THE ALK (D5F3) TEST REPEATED AT A DIFFERENT SITE AND IT CAME BACK NEGATIVE. PRODUCT LABELING STATES THAT THE POSITIVE AGREEMENT RATE BETWEEN VENTANA ALK (D5F3) CDX ASSAY AND VYSIS ALK BREAK-APART FISH PROBE KIT IS 86.0%. IT IS IMPORTANT TO NOTE THE CONCORDANCE RATE BETWEEN IMMUNOHISTOCHEMISTRY (IHC) AND FLUORESCENCE IN SITU HYBRIDIZATION (FISH) FOR ALK BIOMARKER DETECTION IS DEPENDENT ON THE SENSITIVITY OF THE TESTING PERFORMED. IT IS ALSO IMPORTANT TO EMPHASIZE THAT THE ALK PROTEIN APPEARS TO BE MORE SENSITIVE TO PRE-ANALYTICAL FACTORS WHEN COMPARED WITH OTHER LUNG MARKERS DETECTED BY IHC. THE TARGET ANTIGENS OF IHC ASSAYS ARE IMPACTED BY FIXATION TIME, TYPE OF FIXATIVE, AND AGE OF CUT SLIDES, THEREFORE PRE-ANALYTICAL STEPS MUST BE EXECUTED WITH CARE TO ENSURE COMPATIBILITY OF SPECIMEN PREPARATION PRIOR TO STAINING. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE INVESTIGATION DETERMINED THAT THE ROCHE PRODUCT PERFORMED AS INTENDED. A GLOBAL TREND FOR THIS PRODUCT AND FAILURE MODE HAS NOT BEEN IDENTIFIED. MEDWATCH FIELDS A1 AND A2 HAVE BEEN UPDATED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED A FALSE POSITIVE RESULT FOR ONE PATIENT'S SAMPLE TESTED WITH THE VENTANA ALK (D5F3) CDX ASSAY ON A BENCHMARK ULTRA STAINER MODULE. THE SPECIFIC DATE OF THE EVENT IS NOT KNOWN. THE PATIENT'S SAMPLE INITIALLY RESULTED IN A POSITIVE ALK (D5F3) STAINING. THE SLIDE OF THE SAMPLE USED FOR TESTING DID NOT HAVE A CONTROL TESTED ON THE SAME SLIDE. A CONTROL RUN ON A SEPARATE SLIDE STAINED NORMALLY. AFTER SHOWING A POSITIVE RESULT, A SLIDE OF THE PATIENT'S SAMPLE WAS SENT TO ANOTHER SITE AN FISH TESTING WAS RUN ON IT WHICH SHOWED A NEGATIVE RESULT. BASED ON THIS RESULT, THE CUSTOMER DECIDED TO RE-TEST THE TISSUE SAMPLE FROM THE PATIENT. SUBSEQUENT TESTING OF THE PATIENT'S SAMPLE SHOWED NEGATIVE ALK (D5F3) RESULTS. UNKNOWN MOLECULAR TESTING OF THE PATIENT'S SAMPLE SHOWED NEGATIVE RESULTS. THE CUSTOMER ALSO PERFORMED FISH TESTING OF THE PATIENT'S SAMPLE FOR ALK AND ROS1. BOTH TESTS WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767267 VENTANA ALK (D5F3) CDX ASSAY ANAPLASTIC LYMPHOMA KINASE ANTIBODY IMMUNOHISTOCHEMISTRY ASSAY PKW VENTANA MEDICAL SYSTEMS INC. K12260

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female