BEUDAMED
    FDA Adverse Event Death Summary report: N

    BENCHMARK CLASSIC

    MDR report key: 1565396 · Received December 22, 2009

    Report

    Report Number
    2028492-2009-00006
    Event Type
    Death
    Date Received
    December 22, 2009
    Date of Event
    June 1, 2009
    Report Date
    November 22, 2009
    Manufacturer
    VENTANA MEDICAL SYSTEMS, INC.
    Product Code
    KPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VENTANA HAS REQUESTED HISTORICAL PATIENT RECORDS, INSTRUMENT RUN REPORTS, PICTURES OF THE SLIDES, AND THE TEST PROTOCOL USED. HOWEVER, CO HAS BEEN UNABLE TO OBTAIN THE REQUESTED INFORMATION WITHIN THE REQUIRED REPORTING TIME FRAME AND THEREFORE, CANNOT EXCLUDE THE DEVICE FROM THE INCIDENT. HENCE, THE INCIDENT IS BEING REPORTED. THE INSTRUMENT IS UNDER SERVICE CONTRACT AND HAS BEEN MAINTAINED AS SCHEDULED. AT THE TIME OF THE PREVENTATIVE MAINTENANCE, NOTHING WAS NOTICED. A RECENT VISIT PERFORMED IN 2009 BY CO'S APPLICATION SPECIALIST REVEALED THAT THE SYSTEMS WORKED PROPERLY.

    Description of Event or Problem · 1

    ON 07-DEC-2009, THE VENTANA CUSTOMER SERVICE CENTER WAS NOTIFIED THAT TWO NON-VENTANA ANTIBODIES RUN ON A BENCHMARK CLASSIC AUTOMATED STAINER REPORTEDLY LED TO FALSE NEGATIVE RESULTS IN 2009. THE PATIENT PASSED AWAY SEVEN MONTHS LATER, FOR CAUSES THAT REMAIN UNKNOWN. PRE-EXISTING MEDICAL CONDITION REMAINS UNKNOWN, BUT THE COMPLAINT INDICATED THE PATIENT TO HAVE AN ADVANCED DISEASE STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BENCHMARK CLASSIC BENCHMARK CLASSIC KPA VENTANA MEDICAL SYSTEMS, INC. 750-800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death NOVOCASTRA CALRETININ (NCL-L-CD3-565) LOT # UNK| 2 NON-VENTANA IHC ANTIBODIES:| DAKO DESMIN (M0613) LOT# UNKNOWN