BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENCHMARK ULTRA

    MDR report key: 16388801 · Received February 16, 2023

    Report

    Report Number
    2028492-2023-00017
    Event Type
    Malfunction
    Date Received
    February 16, 2023
    Date of Event
    January 13, 2023
    Report Date
    April 11, 2023
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC
    Product Code
    KPA
    UDI-DI
    04015630981052
    PMA / PMN Number
    510K EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGHOUT THE INVESTIGATION AND CONSIDERING THE INFORMATION AND EVIDENCE COLLECTED, A PRODUCT ISSUE WAS NOT FOUND. AFTER EXTENSIVE REVIEW OF THE DATA AND COMMUNICATION WITH THE CUSTOMER, THIS ISSUE APPEARS TO HAVE BEEN CAUSED DUE TO USER ERROR. BASED ON THE INVESTIGATION, THE MOST LIKELY SCENARIO IS THAT THE OPERATOR OPENED THE INSTRUMENT'S REAGENT HOOD TO ADD THE MISSING REAGENTS AND, WHILE DOING SO, MOVED THE SLIDES THAT WERE ON DRAWERS (SLIDE POSITIONS) 24-30 OVER TO DRAWER 5-11 WITHOUT OPENING THE DRAWERS. THE OPERATOR TOOK THE 7 SLIDES THAT THE INSTRUMENT ALREADY SCANNED SLIDE LABELS ON DRAWERS 5-11 AND REPLACED THEM WITH THE 7 SLIDES THAT FAILED TO SCAN ON DRAWERS 24-30. THIS CAUSED THE 7 SLIDES THAT FAILED TO SCAN ON DRAWERS 24-30 TO BE STAINED USING THE PROTOCOLS LOADED ONTO THE RESPECTIVE POSITIONS 5-11. TO BE DETECTED, A SLIDE MUST BE LOADED INTO THE DRAWER CORRECTLY. A SLIDE MUST BE ADDED (LOADED) BY OPENING AND CLOSING THE SLIDE DRAWER. ONLY THEN, WILL THE NEWLY ADDED SLIDE BE DETECTED WHEN SCANNED BY THE INSTRUMENT BARCODE READER TO INITIATE THE START OF THE STAINING RUN. INSTRUCTION IS AVAILABLE IN THE USER MANUAL ON HOW TO LOAD/UNLOAD SLIDES ON THE BENCHMARK ULTRA INSTRUMENT.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED TO SHARE THE CONCLUSIONS OF THE INVESTIGATION.

    Description of Event or Problem · 0

    A CUSTOMER FROM CANADA ALLEGED THAT SEVEN SLIDES (PATIENT ORDERS) APPEAR TO HAVE BEEN STAINED ON THE BENCHMARK ULTRA WITH A DIFFERENT STAINING PROTOCOL THAN WHAT WAS ASSIGNED ON THE SLIDE LABEL (BARCODE) AND INTENDED TO BE USED. THE RESULT WAS REPORTED OUT TO THE TREATING PHYSICIAN FOR ONE OF THESE SEVEN SLIDES, HOWEVER IT WAS CONFIRMED THAT THE PATIENT WAS NOT TREATED BASED ON THE INCORRECTLY STAINED SLIDE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679872 BENCHMARK ULTRA SLIDE STAINER, AUTOMATED KPA VENTANA MEDICAL SYSTEMS INC NA NA 04015630981052

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown