BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIRM ER

    MDR report key: 6592947 · Received May 25, 2017

    Report

    Report Number
    2028492-2017-00002
    Event Type
    Injury
    Date Received
    May 25, 2017
    Date of Event
    January 19, 2017
    Report Date
    May 25, 2017
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC
    Product Code
    NQN
    PMA / PMN Number
    K140465
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THERE IS A DETERIORATION IN PATIENT HEALTH. WE HAVE ASKED THE CUSTOMER MULTIPLE TIMES WITH NO RESPONSE. INVESTIGATION STATEMENT AND CONCLUSION: THERE IS NO INDICATION OF A MALFUNCTION OF VENTANA MEDICAL SYSTEM'S INSTRUMENT OR ASSAY. NO CORRECTIONS TAKEN BY THE MANUFACTURER SINCE NO VENTANA PRODUCT MALFUNCTION IDENTIFIED. HOWEVER INFORMATION WAS PROVIDED TO THE CUSTOMER ON THE "IMPACT OF ENVIRONMENTAL STRESS ON VARIOUS HISTOLOGY SLIDE TYPES". THE CUSTOMER HAS NOW CHANGED FROM HISTOBOND SLIDES TO ANOTHER SLIDE MANUFACTURER (TOMO SLIDES FROM MATSUNAMI). THEY HAVE REPORTED NO ISSUES SINCE SWITCHING SLIDE TYPES. THIS IS AN INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER USED A SAME SLIDE POSITIVE CONTROL TISSUE SECTION WHICH STAINED POSITIVE. PATIENT SAMPLE WAS NEGATIVE AND ACCORDINGLY PATIENT WAS DIAGNOSED TRIPLE NEGATIVE (ER, PR, HER2). SIX WEEKS LATER, THE PATIENT SAMPLE WAS RE-STAINED IN ANOTHER HOSPITAL AND FOUND TO BE ER-POSITIVE. THEY ASSUMED THE REASON FOR THE FAILED STAINING IN THE FIRST RUN WAS THE SLIDE SURFACE PROPERTIES ON THE SLIDES THEY USED. THE CUSTOMER HAS NOW CHANGED FROM HISTOBOND SLIDES TO ANOTHER SLIDE MANUFACTURER (TOMO SLIDES FROM MATSUNAMI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373396 CONFIRM ER NQN VENTANA MEDICAL SYSTEMS INC 05278406001 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1