BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BENCHMARK SPECIAL STAINS SYSTEM

    MDR report key: 22861799 · Received August 21, 2025

    Report

    Report Number
    2028492-2025-02572
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    July 24, 2025
    Report Date
    November 5, 2025
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC.
    Product Code
    KPA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOR THE GMS II STAINING KIT, THE FOLLOWING TWO LOT NUMBERS WERE USED: M23983, WITH AN EXPIRATION DATE OF 13-MAY-2026 ON SYSTEMS 1 AND 2. M26553, WITH AN EXPIRATION DATE OF 09-JUN-2026 ON SYSTEM 2. PAS STAINING KIT LOT NUMBER M20114, WITH AN EXPIRATION DATE OF 16-OCT-2025 ON SYSTEM 2. LIGHT GREEN FOR PAS LOT NUMBER K22452, WITH AN EXPIRATION DATE OF 08-MAY-2025 ON SYSTEM 2. THE CUSTOMER REPORTED THAT THE ISSUE WAS INITIALLY THOUGHT TO BE LIMITED TO SYSTEM 1 SINCE IT WAS OVERDUE FOR ROUTINE DECONTAMINATION. THE DECONTAMINATION WAS REPORTED TO NOT BE PERFORMED DUE TO MECHANICAL ISSUES. THE SYSTEM WAS REPORTEDLY REMOVED FROM PERFORMING FUNGAL STAINS. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PATIENT RELEVANT HISTORY WAS PROVIDED FOR THE PATIENT WHO ALLEGEDLY RECEIVED ADDITIONAL LUNG BIOPSIES.

    Additional Manufacturer Narrative · 0

    A FUNGAL CONTAMINATION ISSUE WAS CONFIRMED AND APPEARS TO BE LOCALIZED AT THIS SITE. THE ROCHE FIELD PERSONNEL RECTIFIED THE ISSUE BY PERFORMING DECONTAMINATION ON THE INSTRUMENTS AND REPLACING NECESSARY BOTTLES, FILTERS, AND COMPONENTS. AS A PREVENTIVE MEASURE, THE CUSTOMER ALSO AGREED TO MAKE SMALLER BATCHES OF BULK FLUIDS GOING FORWARD. THE FIELD RETRAINED THE CUSTOMER ON THE DECONTAMINATION PROCESS.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED THAT THERE WAS AN INCIDENT WHERE THREE PATIENTS WERE MIS-DIAGNOSED AS HAVING GMS POSITIVE FUNGAL ELEMENTS WHEN TESTED ON TWO BENCHMARK SPECIAL STAINS SYSTEMS. THE INVOLVED SYSTEMS ARE SYSTEM 1 (SERIAL NUMBER (B)(6)) AND SYSTEM 2 (SERIAL NUMBER (B)(6)). SAMPLES FROM THE PATIENTS WERE REPORTED TO BE STAINED USING THE GMS AND PAS STAINING PROTOCOLS. THE FOLLOWING STAINING PRODUCTS WERE INVOLVED: GMS II STAINING KIT, PAS STAINING KIT, AND LIGHT GREEN FOR PAS. IT IS NOT KNOWN WHICH OF THE TWO SYSTEMS EACH PATIENT'S SAMPLE WAS PROCESSED ON. FOR EACH PATIENT, THE CUSTOMER REPORTED THAT THE EXPECTED OUTCOME WAS THE ABSENCE OF FUNGAL CONTAMINATION FROM THE STAINING PROCESS. THE CUSTOMER REPORTED THAT IT IS UNCLEAR IF ANTIFUNGAL MEDICATION WAS PRESCRIBED TO THE PATIENTS, BUT ADDITIONAL LUNG BIOPSIES ALLEGEDLY WERE PERFORMED ON ONE PATIENT AND CONFIRMATORY MOLECULAR PROFILING WAS ALLEGEDLY PERFORMED ON ANOTHER PATIENT. IT WAS ALLEGED THAT FUNGAL CONTAMINATION IN THE SYSTEMS DEPOSITED FUNGAL ORGANISMS ON THE GMS/PAS SLIDES THAT THE PATHOLOGIST INTERPRETED AS PATHOGENIC FUNGAL ORGANISMS INTRINSIC TO THE PATIENT TISSUE. THE CUSTOMER REPORTED THERE WERE OTHER CASES WHERE FUNGAL CONTAMINATION WAS IDENTIFIED AND REPORTED AS SUCH. NO SPECIFIC DETAILS WERE PROVIDED ON THESE OTHER CASES. INSTANCES OF THE DEPOSITING OF FUNGAL CONTAMINANTS WAS ALLEGED TO HAVE BEEN OCCURRING SINCE (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466551 BENCHMARK SPECIAL STAINS SYSTEM SLIDE STAINER, AUTOMATED KPA VENTANA MEDICAL SYSTEMS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other