BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENCHMARK ULTRA SYSTEM

    MDR report key: 24952169 · Received April 22, 2026

    Report

    Report Number
    2028492-2026-01538
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    March 30, 2026
    Report Date
    May 13, 2026
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC.
    Product Code
    KPA
    UDI-DI
    04015630981052
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A REAGENT POSITION ISSUE DURING A RUN WITH THE BENCHMARK ULTRA INSTRUMENT. DURING THE RUN, THE SOFTWARE DISPLAYED A NOTIFICATION STATING THAT THE HP REAGENT IN POSITION 11 WAS INSUFFICIENT TO COMPLETE THE CYCLES. WHEN THE CUSTOMER ATTEMPTED TO REPLACE THE SYRINGE IN THE CAROUSEL, THE HP REAGENT WAS ACTUALLY FOUND IN POSITION 12 INSTEAD OF 11. UPON VISUAL INSPECTION, THE CUSTOMER NOTED THAT ALL REAGENT SYRINGES WERE PHYSICALLY OFFSET BY ONE POSITION (N+1) COMPARED TO THE SOFTWARE DISPLAY. FOLLOWING THE RUN, THE CUSTOMER CLOSED THE SOFTWARE TO UPDATE THE PC SYSTEM TIME (TO ADJUST DAYLIGHT SAVING TIME). THEY THEN RESTARTED THE CYCLES WITHOUT PHYSICALLY MOVING THE SYRINGES. DURING THE SUBSEQUENT SYRINGE SCAN, THE SOFTWARE POSITIONS AND PHYSICAL POSITIONS WERE CONSISTENT AND CORRECTLY ALIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405589 BENCHMARK ULTRA SYSTEM SLIDE STAINER, AUTOMATED KPA VENTANA MEDICAL SYSTEMS INC. 04015630981052

    Patients

    Seq Age Sex Outcome Treatment
    1