BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENCHMARK GX, STAINER MODULE

    MDR report key: 19850163 · Received July 29, 2024

    Report

    Report Number
    2028492-2024-02188
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 27, 2024
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC.
    Product Code
    KPA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE STAIN LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED, BUT NOT PROVIDED. THE FIELD APPLICATION SPECIALIST REPAIRED THE SOFTWARE TABLES USED BY THE SYSTEM SOFTWARE. THE ISSUE WAS RESOLVED AFTER THIS ACTION. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE ALLEGATION HAS BEEN VERIFIED AS A SOFTWARE ISSUE IN VENTANA SYSTEM SOFTWARE (VSS) 12.5.4, AS VSS CAN DUPLICATE THE USIDS OF NEW INTERNAL ORDERS, POTENTIALLY LEADING TO PROTOCOL READ MISMATCHES AND INAPPROPRIATE STAINING. CUSTOMERS HAVE BEEN NOTIFIED OF THE ISSUE AND THE ISSUE IS ADDRESSED IN A NEW SOFTWARE UPDATE. THE ISSUE IS UNLIKELY TO CAUSE HARM. ALTHOUGH THE FAILURE MODE COULD THEORETICALLY LEAD TO A FALSE NEGATIVE OR FALSE POSITIVE RESULT, GIVEN THE LOW FREQUENCY AND HIGH RATE OF DETECTABILITY OF THE FAILURE MODE, COMBINED WITH THE PRESENCE OF CLINICAL MITIGATIONS SUCH AS SLIDE CONTROLS, IT IS NOT LIKELY THAT THIS FAILURE MODE WOULD CAUSE ADVERSE HEALTH CONSEQUENCES.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THERE WERE ISSUES WITH DIFFERENT STAININGS ON THE BENCHMARK GX STAINER SYSTEM. PATIENT SAMPLE SLIDES WERE ALLEGEDLY STAINED WITH THE WRONG STAINING REAGENTS. SOME OF THE SAMPLES WERE NOT EVEN STAINED. SLIDES THAT SHOULD HAVE BEEN STAINED FOR KI67 HAD HER2 STAINING INSTEAD. OTHER STAINS AFFECTED INCLUDED ER, PR, AND E-CADERIN. THE CUSTOMER CONFIRMED THAT THE SLIDES WERE CORRECTLY LABELED. THE INCORRECT STAINING RESULTS WERE RECOGNIZED BY THE PATHOLOGIST AND NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994147 BENCHMARK GX, STAINER MODULE SLIDE STAINER, AUTOMATED KPA VENTANA MEDICAL SYSTEMS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown