BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1516913 · Received October 16, 2009

    Report

    Report Number
    2028492-2009-00002
    Event Type
    Malfunction
    Date Received
    October 16, 2009
    Date of Event
    September 17, 2009
    Report Date
    September 17, 2009
    Manufacturer
    VENTANA MEDICAL SYSTEMS, INC.
    Product Code
    MVC
    PMA / PMN Number
    P990081
    Removal / Correction Number
    2028492-09/08/09-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 PATIENTS FOR WHOM HERCEPTIN TREATMENT IS CONSIDERED. LIGHT STAINING WITH LOT #680957 IS DETECTABLE IF APPROPRIATE LOW-EXPRESSING/ LOW-LEVEL CONTROLS ARE UTILIZED. PATHOLOGISTS WHO ARE FAMILIAR WITH THE USUAL APPEARANCE AND INTENSITY OF THEIR CONTROL TISSUES MAY RECOGNIZE THE PROBLEM AS LIGHTER THEN USUAL CONTROL TISSUE STAINING. 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 ETC.). LABORATORIES ARE INSTRUCTED TO USE THEIR OWN CONTROLS AND PATHOLOGISTS ARE FAMILIAR WITH THE PERFORMANCE OF THESE CONTROLS IN THEIR LABORATORY. INVESTIGATION CONFIRMED LOT #680957 STAINED LIGHTER WHEN COMPARED TO OTHER REFERENCE LOTS OF PATHWAY HER2 (4B5). THE LIGHT STAINING COULD RESULT IN SCORES OF UP TO A FULL POINT REDUCTION IN THE CLINICAL SCORE, WHICH COULD PREVENT FURTHER EVALUATION AND ALLOW PATIENTS TO GO UNTREATED. THIS ISSUE OF LIGHT STAINING IS LIMITED TO LOT #680957, AND THERE HAVE BEEN NO REPORTED CASES OF PATIENT DIAGNOSIS BEING ADVERSELY AFFECTED FROM THIS ISSUE. VENTANA MEDICAL SYSTEM HAS NOTIFIED ALL CUSTOMER WHO HAVE RECEIVED LOT #680957 AND THIS LOT HAS BEEN RECALLED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED THE VENTANA CUSTOMER SERVICE CENTER SUBSEQUENT TO RECEIVING A MEDICAL DEVICE RECALL LETTER FOR LOT #680957 PATHWAY HER2 (4B5). AS A RESULT OF THE RECOMMENDATIONS IN THE RECALL, A REVIEW OF THEIR RECORDS SHOWED THAT THEY HAD ONE (1) PATIENT THAT REQUIRED RETESTING, FOR WHICH THE RESULTS ARE STILL PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HER-2/NEU (4B5) RABBIT MONOCLONAL ANTIBODY PATHWAY HER2 (4B5) MVC VENTANA MEDICAL SYSTEMS, INC. 790-2991 680957

    Patients

    Seq Age Sex Outcome Treatment
    1 NA