BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENCHMARK GX, STAINER MODULE

    MDR report key: 19519710 · Received June 12, 2024

    Report

    Report Number
    2028492-2024-01746
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    March 4, 2024
    Report Date
    June 17, 2024
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC.
    Product Code
    KPA
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANTI-ESTROGEN RECEPTOR (SP1) REAGENT LOT NUMBER WAS J32640, WITH AN EXPIRATION DATE OF 12-DEC-2024. THE ANTI-PROGESTERONE RECEPTOR (1E2) REAGENT LOT NUMBER WAS J31006, WITH AN EXPIRATION DATE OF 27-NOV-2024. THE ANTI-KI-67 (30-9) REAGENT LOT NUMBER WAS J33538, WITH AN EXPIRATION DATE OF 15-FEB-2025. THE P16 REAGENT LOT NUMBER WAS K00045, WITH AN EXPIRATION DATE OF 30-JAN-2025. THE FIELD SERVICE ENGINEER FOUND THE INSTRUMENT TO BE IN PERFECT CONDITION INSIDE AND OUTSIDE. PREPARATION TANKS, PIPES, AND FILTERS WERE LIKE NEW. NO LEAKS WERE FOUND. PERFORMANCE TESTING RAN SUCCESSFULLY. THE SYSTEM COMPUTER DID NOT ENCOUNTER SOFTWARE PROBLEMS OR SLOWDOWNS. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    NONE OF THE PROVIDED INFORMATION REASONABLY SUGGESTS THERE WAS A REAGENT MALFUNCTION. COMPLAINT DATA FOR THE AFFECTED REAGENT LOTS DO NOT INDICATE ANY OTHER SIMILAR ISSUES. BATCH RECORDS FOR THE AFFECTED REAGENTS DID NOT INDICATE ANY NON-CONFORMANCES DURING THE FINAL INSPECTION OF THE PRODUCTS. PER PRODUCT LABELING FOR ANTI-ESTROGEN RECEPTOR (SP1) AND ANTI-PROGESTERONE RECEPTOR (1E2) REAGENTS, THESE PRODUCTS ARE TO BE RUN ON EITHER THE BENCHMARK XT OR THE BENCHMARK ULTRA/ULTRA PLUS INSTRUMENTS, AND NOT THE VMS BENCHMARK GX STAINER. THE PROVIDED SLIDE IMAGES WERE REVIEWED IN COLLABORATION WITH A ROCHE PATHOLOGIST. IT WAS NOTED THE MICROSCOPIC IMAGES PROVIDED FOR EACH PATIENT DEPICT TISSUE CUTS WITH DIFFERENT MORPHOLOGY THAT DO NOT APPEAR TO BE FROM SERIAL SECTIONS OF TISSUE. IT WAS NOTED THE NEGATIVE TISSUE SLIDES EXHIBITED NON-STAINING ON THE PATIENT TISSUE, EVIDENCE OF AN INSTRUMENT HARDWARE ISSUE. THE METHOD SHEETS FOR THE ASSOCIATED ASSAYS STATE A POSITIVE TISSUE CONTROL MUST BE INCLUDED WITH EACH STAINING RUN. FURTHER, LABELING STATES THAT A QUALIFIED PATHOLOGIST EXPERIENCED IN IMMUNOHISTOCHEMISTRY PROCEDURES MUST EVALUATE POSITIVE AND NEGATIVE CONTROLS AND QUALIFY THE STAINED PRODUCT BEFORE INTERPRETING RESULTS. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY HAD AN ALLEGED DISCREPANCY IN SEVERAL ANTIBODY RESULTS FOR ONE ENDOMETRIAL PATIENT SAMPLE TESTED ON A BENCHMARK GX, STAINER MODULE INSTRUMENT. RESULTS FOR THE FOLLOWING TESTS WERE REPORTED AS ERRONEOUS (FALSE-NEGATIVE) STAINING RESULTS TO THE PHYSICIAN: ANTI-ESTROGEN RECEPTOR (SP1), ANTI-PROGESTERONE RECEPTOR (1E2), ANTI-KI-67 (30-9), AND P16. THE CUSTOMER NOTED THAT WITHIN THE SAME TESTING RUN, SOME SLIDES WERE COMPLETELY SILENT WITH THE PRESENCE OF HEMATOXYLIN, WHILE OTHERS WERE WEAKLY POSITIVE. INTERNAL CONTROLS WERE NOT TESTED. NO FALSE DIAGNOSES OCCURRED FOR OTHER SLIDES IN THE SAME RUN. THE PATIENT WENT TO A SECOND CENTER FOR THE SURGICAL TREATMENT OF THE DIAGNOSED NEOPLASM (ENDOCERVICAL ADENOCARCINOMA). THE PATIENT UNDERWENT SURGERY TO REMOVE THE UTERUS. THE SURGERY WAS PLANNED REGARDLESS OF THE DIAGNOSIS. ON THE SURGICAL SPECIMEN, STAININGS WERE REPEATED AND THERE WAS A DIFFERENT DIAGNOSTIC OUTCOME (ENDOMETRIAL CARCINOMA). UPON RECEIVING THE RESULTS FROM THE SECOND CENTER, THE INITIAL SAMPLE WAS RETESTED FOR 2 OF THE AFFECTED MARKERS, ANTI-ESTROGEN RECEPTOR (SP1) AND ANTI-PROGESTERONE RECEPTOR (1E2). POSITIVE RESULTS WERE RECEIVED UPON RETESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152924 BENCHMARK GX, STAINER MODULE SLIDE STAINER, AUTOMATED KPA VENTANA MEDICAL SYSTEMS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown