BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOND AND NOVOCASTRA

    MDR report key: 2492795 · Received March 9, 2012

    Report

    Report Number
    3004859032-2012-00002
    Event Type
    Malfunction
    Date Received
    March 9, 2012
    Date of Event
    February 1, 2012
    Report Date
    March 8, 2012
    Manufacturer
    LEICA BIOSYSTEMS NEWCASTLE LTD
    Product Code
    MYA
    PMA / PMN Number
    K060227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE SLIDES FROM (B)(6) HOSPITAL AND SUBSEQUENT ASSESSMENT AT (B)(6) HAS CONFIRMED THAT THE PROTOCOL AT (B)(6) HOSPITAL, WHICH EMPLOYED A MORE AGGRESSIVE PRETREATMENT, IS THE MOST LIKELY CAUSE OF STAINING PATTERN NOTED AT BY THE CUSTOMER. WHEN AN APPROPRIATE EPITOPE RETRIEVAL BUFFER WAS EMPLOYED THE STAINING WAS NOT OBSERVED. ADVISED CUSTOMER TO REVALIDATE THE ANTIBODY USING THE APPROPRIATE EPITOPE RETRIEVAL SOLUTION. THE COMPLAINT IS STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER WE COMPLETE OUR INVESTIGATIONS.

    Description of Event or Problem · 1

    CUSTOMER RAISED QUERY ((B)(4)) REGARDING POTENTIAL FALSE POSITIVE RESULTS OBTAINED USING LEICA ESTROGEN RECEPTOR CLONE ((B)(4)). DISCORDANT RESULTS WERE REPORTED ON A RETROSPECTIVE VALIDATION COHORT WHEN COMPARED WITH STAINING RESULTS OBTAINED WITH COMPETITOR ER ANTIBODY. THE SAME STAINING PATTERN WAS SUBSEQUENTLY OBSERVED IN PT SAMPLES AND THE HOSPITAL HAS SUSPENDED ER TESTING SERVICE RESULTING IN A POTENTIAL DELAY IN PT DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOND AND NOVOCASTRA IMMUNOHISTOCHEMISTRY REAGENT MYA LEICA BIOSYSTEMS NEWCASTLE LTD NCL-ER-6F11 6008295

    Patients

    Seq Age Sex Outcome Treatment
    1