BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALK (D5F3)

    MDR report key: 22873236 · Received August 22, 2025

    Report

    Report Number
    2028492-2025-02589
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    July 1, 2023
    Report Date
    October 23, 2025
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC.
    Product Code
    NJT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE ANALYZER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    A REVIEW OF GLOBAL COMPLAINT DATA INDICATES NO OTHER SIMILAR CASES AGAINST VENTANA ANTI-ALK (D5F3) RABBIT MONOCLONAL PRIMARY ANTIBODY (06679072001), LOT K11270. THE CUSTOMER USED A NON-STANDARD COUNTERSTAIN, MAYER-HARRIS HAEMATOXYLIN, WHICH IS NOT VALIDATED FOR USE WITH THE VENTANA ANTI-ALK (D5F3) ASSAY. THE ASSAY IS DESIGNED FOR USE WITH VENTANA'S HEMATOXYLIN II AND BLUING REAGENT, AND THE USE OF AN ALTERNATIVE COUNTERSTAIN COULD LEAD TO ALTERED STAINING INTENSITY OR NON-SPECIFIC BINDING, COMPLICATING INTERPRETATION. PRODUCT LABELING STATES: "ANY DEVIATION FROM RECOMMENDED TEST PROCEDURES MAY INVALIDATE EXPECTED RESULTS. APPROPRIATE CONTROLS MUST BE EMPLOYED AND DOCUMENTED. USERS WHO DEVIATE FROM RECOMMENDED TEST PROCEDURES MUST ACCEPT RESPONSIBILITY FOR INTERPRETATION OF PATIENT RESULTS." A NEGATIVE CONTROL WAS NOT USED. PRODUCT LABELING STATES: "A MATCHED NEGATIVE REAGENT CONTROL SLIDE MUST BE RUN FOR EVERY SPECIMEN TO AID IN THE INTERPRETATION OF RESULTS. RABBIT MONOCLONAL NEGATIVE CONTROL IG, A NEGATIVE REAGENT CONTROL ANTIBODY, IS SPECIFICALLY MATCHED FOR THIS ASSAY AND IS USED IN PLACE OF THE PRIMARY ANTIBODY TO EVALUATE NONSPECIFIC STAINING." THE ALK PROTEIN MAY BE MORE SENSITIVE TO PRE-ANALYTICAL FACTORS WHEN COMPARED WITH OTHER LUNG MARKERS DETECTED BY IMMUNOHISTOCHEMISTRY (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. THE ROOT CAUSE OF THE STAINING DIFFERENCE BETWEEN THE BLOCKS CANNOT BE DETERMINED, AND THE RESULT CANNOT BE CONFIRMED AS A FALSE POSITIVE DUE TO THE TIME PASSED AND INABILITY TO RETEST THE ORIGINAL SAMPLE, ALTHOUGH THE SUBSEQUENT NEGATIVE ALK RESULTS BY MOLECULAR AND IHC TESTING IN RELATED TUMOR BLOCKS SUGGEST THAT THIS INITIAL POSITIVE RESULT WAS NOT BIOLOGICALLY REPRESENTATIVE OF THE TUMOR. FURTHER, THERE IS A POTENTIAL CONTRIBUTION FROM THE USE OF A THIRD-PARTY COUNTERSTAIN.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE VENTANA ANTI-ALK (D5F3) RABBIT MONOCLONAL PRIMARY ANTIBODY ASSAY RESULTS FOR ONE PATIENT SAMPLE TESTED ON A BENCHMARK ULTRA STAINER MODULE. THE INITIAL TEST WAS CONDUCTED IN 2023 USING ONE BLOCK FROM THE PATIENT¿S NON-SMALL CELL LUNG CANCER (NSCLC) TUMOR SAMPLE. THE RESULT WAS POSITIVE. THE REPEAT TESTS WERE CONDUCTED IN 2025 USING 3 ADDITIONAL BLOCKS FROM THE SAME TUMOR AREA USING DIFFERENT METHODS (IMMUNOHISTOCHEMISTRY (IHC) PANEL, FLUORESCENCE IN SITU HYBRIDIZATION (FISH) TESTING, AND NEXT GENERATION SEQUENCING (NGS)). THE INITIAL BLOCK WAS NOT AVAILABLE. THE RESULTS WERE ALL NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2666894 ALK (D5F3) IMMUNOHISTOCHEMISTRY REAGENTS AND KITS NJT VENTANA MEDICAL SYSTEMS INC. K11270

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown