BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONFIRM ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY

    MDR report key: 2507887 · Received March 20, 2012

    Report

    Report Number
    2028492-2011-00001
    Event Type
    Other
    Date Received
    March 20, 2012
    Date of Event
    February 4, 2011
    Report Date
    March 7, 2011
    Manufacturer
    VENTANA MEDICAL SYSTEMS, INC.
    Product Code
    MVC
    PMA / PMN Number
    P990081
    Removal / Correction Number
    NONE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 PTS FOR WHOM HERCEPTIN TREATMENT IS CONSIDERED. LIGHT OR INCONSISTENT STAINING WITH LOT A00156 CONFIRM, (USE FULL NAME OF THE PRODUCT) ANTI-HER-2/NEU (4B5) IS DETECTABLE IF APPROPRIATE CONTROLS ARE UTILIZED. NON-STAINING IN PARTICULAR IS AN IMMEDIATELY EVIDENT INDICATOR THAT STAIN RUN INVESTIGATION IS NECESSARY. THE TEST IS DESIGNED TO BE READ BY A PATHOLOGIST WHO HAS KNOWLEDGE OF PROPER INTERPRETATION OF HER2 SCORING AS WELL AS THE FACTORS THAT CAN INFLUENCE SCORES (I.E. RETRIEVAL, TISSUE FIXATION, INSTRUMENT VARIABILITY, SLIDE SURFACE VARIABILITY, ETC.). LABORATORIES ARE INSTRUCTED TO USE THEIR OWN CONTROLS AND PATHOLOGISTS ARE FAMILIAR WITH THE PERFORMANCE OF THESE CONTROLS IN THEIR LABORATORY. THE ISSUE STATES THAT LOT #A00156 CONFIRM ANTI-HER-2/NEU (4B5) DID NOT RECEIVE PROPER STAINING. THERE IS LACK OF CLARITY IF THE REQUIRED CONTROL SLIDES WERE USED, BUT IMPROPER STAINING WAS NOT CAUGHT OR CONSIDERED BY THE PATHOLOGIST. CUSTOMER CONTACTS HAVE REPORTED NO ADVERSE PT HEALTH EFFECTS SPECIFIC TO THIS ERRONEOUS REPORTING TO PHYSICIAN. INVESTIGATION DATA SHOW THAT THE VENTANA REAGENT AND INSTRUMENTATION ARE FUNCTIONING PROPERLY.

    Description of Event or Problem · 1

    CONFIRM ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY - BREAST CANCER PT (B)(6) SAMPLE FALSE NEGATIVE TISSUE DIAGNOSTIC RESULT REPORTED TO PT'S PHYSICIAN. PT MISSED HERCEPTIN TREATMENT FROM LATE (B)(6) 2010 TO (B)(6) 2011. TREATMENT HAS SINCE RESUMED. SITE REPORTS NO PERCEIVED HEALTH IMPACT TO PT. COMPLAINT STATES THAT CONTROL SLIDES SHOWING STAINING ISSUES WERE NOT CAUGHT BEFORE REPORTING TO THE DOCTOR. INVESTIGATION SHOWS NO REAGENT OR INSTRUMENT MALFUNCTION BY MFR. PATHWAY ANTI-HER-2/NEU (45B) RABBIT MONOCLONAL PRIMARY ANTIBODY CATALOG NUMBER 790-2991 IS A SIMILAR PRODUCT MARKETED IN THE USA UNDER PMA P990881.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFIRM ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY CONFIRM ANTI-HER-2/NEU (4B5) MVC VENTANA MEDICAL SYSTEMS, INC. 800-2996 A00156

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention