BEUDAMED
    FDA Adverse Event Summary report: N

    PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

    MDR report key: 3002990 · Received March 13, 2013

    Report

    Report Number
    2028492-2013-00001
    Date Received
    March 13, 2013
    Date of Event
    January 15, 2013
    Report Date
    February 13, 2013
    Manufacturer
    VENTANA MEDICAL SYSTEMS, INC.
    Product Code
    MVC
    PMA / PMN Number
    P990081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO MALFUNCTION OF A VENTANA PRODUCT ASSOCIATED WITH THE INCIDENT REPORTED. A PROTOCOL USED BY THE USER FACILITY INCLUDED A CELL CONDITIONING TIME THAT IS INADEQUATE TO ENSURE APPROPRIATE ANTIGEN RETRIEVAL IS ACCOMPLISHED. WHEN THE PATIENT TISSUE WAS RETESTED WITH THE VENTANA PRODUCT USING THE RECOMMENDED PROTOCOL THE TISSUE IN QUESTION RETURNED A POSITIVE RESULT. IT SHOULD BE NOTED THAT OTHER SAMPLES THAT ORIGINALLY PRODUCED NEGATIVE RESULTS FOR HER-2 AT THIS USER FACILITY ALSO REMAINED NEGATIVE UPON RETESTING. HOWEVER, THE SHORT CELL CONDITIONING TIME USED IN THE USER FACILITY STAINING PROTOCOL CREATED A POTENTIAL FOR FALSE NEGATIVE RESULTS FOR TISSUE THAT WAS LOW EXPRESSING FOR HER-2. THERE WAS NO NEED TO EVALUATE THE PRODUCT AS CONTROL TISSUES AND RETESTS STAINED APPROPRIATELY AS DID HIGH EXPRESSING HER-2 TISSUE EVEN WITH THE LOW CELL CONDITIONING TIME. THE INFORMATION RELATED TO THE CURRENT HEALTH OF THE PATIENT AFFECTED BY THE ORIGINAL NEGATIVE HER-2 RESULT IS THAT THE PATIENT IS BEING TREATED WITH CHEMOTHERAPY (FLUOR-URACIL, EPIRUBICINE E CYCLOPHOSPHAMIDE). AS OF THE DATE OF THIS SUBMISSION, VENTANA DOES NOT HAVE INFORMATION ABOUT WHETHER THIS PATIENT WOULD HAVE BEEN STARTED ON HERCEPTIN THERAPY IN ADDITION TO THE CHEMOTHERAPY REGIMINE. THE CUSTOMER SITE HAS CORRECTED THEIR PROTOCOL WITHIN THE RECOMMENDED PARAMETERS OF THE PACKAGE INSERT.

    Description of Event or Problem · 1

    A CUSTOMER SITE IN ITALY REPORTED THAT A NEW PATHOLOGIST THAT RECENTLY JOINED THE HOSPITAL STAFF HAD REVIEWED THE SITE'S BREAST CANCER SCREENING CASES FOR HER-2 RESULTS AND QUESTIONED THE NUMBER OF 0/1+/2+ CASES (COMPARED TO AVAILABLE LITERATURE). THE SITE DECIDED TO REVIEW ALL CASES FROM 2012 TO PRESENT AND SET ASIDE SUSPECT CASES DEPENDING ON THE HER-2 SLIDE/OTHER BREAST PANEL MARKER RESULTS/HEMATOXYLIN AND EOSIN SLIDE RESULTS/PATIENT HISTORY FOR RE-EVALUATION. THE PATHOLOGIST WANTED TO BE SURE THAT ANY CASES ORIGINALLY SCORED AS NEGATIVE WERE CORRECT. OF ALL THE PATIENT SLIDES REVIEWED IN THIS RETROSPECTIVE ANALYSIS, ONE CASE THAT WAS ORIGINALLY SCORED AS 0 FOR HER-2 HAS BEEN SCORED AS 2+ UPON RETEST. THIS 2+ IMMUOHISTOCHEMISTRY RESULT HAS ALSO BEEN CONFIRMED AS AMPLIFIED HER-2 POSITIVE USING IN-SITU HYBRIDIZATION AS A CONFIRMATORY TEST. THE SITE USED VENTANA PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY TO TEST THE PATIENT TISSUE FOR HER-2 EXPRESSION.THE INTENDED USE FOR THE PRODUCT FOLLOWS:THIS ANTIBODY IS INTENDED FOR IN VITRO DIAGNOSTIC USE.VENTANA MEDICAL SYSTEMS, INC.'S (VENTANA) PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (PATHWAY HER2 (4B5)) IS A RABBIT MONOCLONAL ANTIBODY INTENDED FOR LABORATORY USE FOR THE SEMI-QUANTITATIVE DETECTION OF HER2 ANTIGEN IN SECTIONS OF FORMALIN-FIXED, PARAFFIN-EMBEDDED NORMAL AND NEOPLASTIC TISSUE ON A VENTANA AUTOMATED IMMUNOHISTOCHEMISTRY SLIDE STAINING DEVICE. IT IS INDICATED AS AN AID IN THE ASSESSMENT OF BREAST CANCER PATIENTS FOR WHOM HERCEPTIN TREATMENT IS CONSIDERED.THE INVESTIGATION CONDUCTED TO DATE HAS RESULTED IN A DETERMINATION THAT THIS SITE IN ITALY WAS USING A STAINING PROTOCOL THAT WAS NOT COMPLETELY CONSISTENT WITH THE PROTOCOL DEFINED IN THE CURRENT PACKAGE INSERT FOR THE PRODUCT. THE CUSTOMER WAS USING A CELL CONDITIONING STEP (ANTIGEN UNMASKING) OF 8 MINS. THIS PROTOCOL WAS BEING RUN ON A VENTANA BENCHMARK ULTRA STAINER MODULE. THE RECOMMENDED TIME FOR CELL CONDITIONING FOR THE HER-2 4B5 ASSAY IS 36 MINS. THIS DECREASE IN CELL CONDITIONING TIME WOULD EXPLAIN WHY AN ORIGINAL RESULT MAY HAVE STAINED WEAKLY DUE TO INADEQUATE ANTIGEN RETRIEVAL. POSITIVE CONTROLS AT THIS SITE HAVE STAINED APPROPRIATELY AND RETESTS OF PATIENT TISSUE USING THE SAME VENTANA PRODUCT WITH THE RECOMMNEDED PROTOCOL STAINED APPROPRIATELY INDICATING NO MALFUNCTION OF PRODUCT PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105687 PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY SYSTEM, TEST, HER-2 NEU, IHC MVC VENTANA MEDICAL SYSTEMS, INC. NA C03664

    Patients

    Seq Age Sex Outcome Treatment
    1 Other