BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENCHMARK ULTRA

    MDR report key: 19613469 · Received June 26, 2024

    Report

    Report Number
    2028492-2024-01859
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    May 29, 2024
    Report Date
    June 28, 2024
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC.
    Product Code
    KPA
    UDI-DI
    04015630981052
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. A REVIEW OF THE INTERNAL DATA SHOWED THAT THE BATCH WAS RELEASED WITHIN SPECIFICATIONS. FURTHERMORE, A TREND WAS NOT IDENTIFIED FOR THE PRODUCT. DURING THE INVESTIGATION, IT WAS IDENTIFIED THAT CONTROLS WERE NOT INCLUDED IN THE INITIAL RUN BUT ONLY INCLUDED IN THE FOLLOW-UP TESTING DONE ON THE BENCHMARK ULTRA INSTRUMENT (AFTER THE INITIAL INCORRECT TEST RESULTS HAD BEEN REPORTED TO THE PHYSICIAN/PATIENT), PER THE METHOD SHEET, CONTROL TISSUES ARE REQUIRED TO VERIFY ASSAY PERFORMANCE. POSITIVE CONTROL TISSUE MUST BE RUN FOR EACH SET OF TEST CONDITIONS AND WITH EVERY PATHWAY ANTI-HER2 (4B5) ANTIBODY STAINING PROCEDURE PERFORMED. THE SAME TISSUE USED FOR THE POSITIVE TISSUE CONTROL MAY BE USED AS THE NEGATIVE TISSUE CONTROL. ADDITIONALLY, A NEGATIVE REAGENT CONTROL MUST BE RUN FOR EVERY SPECIMEN TO AID IN THE INTERPRETATION OF RESULTS. A PERFORMANCE CHECK WAS PERFORMED ON THE INSTRUMENT TO EVALUATE THE INSTRUMENT PERFORMANCE. IT WAS REPORTED THAT ALL TEST RESULTS WERE IN SPECIFICATION, AND NO HARDWARE ADJUSTMENTS WERE REQUIRED. PER THE FIELD SAFETY ENGINEER, THIN, WHITE DEBRIS WERE FOUND IN THE EZ PREP BULK REAGENT CONTAINER. IT WAS REPORTED THAT DECONTAMINATION HAD NOT BEEN PERFORMED SINCE MARCH 2023. BIOFILMS CAN FORM AS A RESULT OF UNADDRESSED MICROBIAL CONTAMINATION WITHIN THE SYSTEM. THEY ARE TYPICALLY SEEN WHERE WATER QUALITY IS INSUFFICIENT AND/OR INSTRUMENT MAINTENANCE SCHEDULES ARE NOT WELL ADHERED TO. BASED ON THE INVESTIGATION AND AVAILABLE INFORMATION, THE PROBABLE ROOT CAUSE FOR THE FALSE NEGATIVE RESULT IS CONTAMINATION IN THE BENCHMARK ULTRA, DUE TO A LACK OF ADHERENCE TO THE RECOMMENDED MAINTENANCE AND DECONTAMINATION PROCEDURES. IT IS RECOMMENDED THAT THE CUSTOMER CONTINUES UTILIZING ADEQUATE DI WATER AND FOLLOWING THE GUIDANCE PROVIDED IN THE OPERATOR MANUAL FOR QUARTERLY DECONTAMINATION OF THE INSTRUMENTS AND BOTTLES USING A QUATERNARY DISINFECTANT.

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS K08001 WITH AN EXPIRATION DATE OF 16-OCT-2024. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS WITH THE PATHWAY ANTI-HER2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY FOR ONE PATIENT TESTED ON A BENCHMARK ULTRA STAINER MODULE. THE ALLEGED SAMPLE INITIALLY GENERATED A NEGATIVE RESULT. THE PHYSICIAN QUESTIONED THE RESULT AND REQUESTED A REPEAT. THE SAMPLE WAS REPEATED ON A COMPETITOR'S DEVICE (LEICA), GENERATING A POSITIVE RESULT USING THE SAME ANTIBODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703046 BENCHMARK ULTRA SLIDE STAINER, AUTOMATED KPA VENTANA MEDICAL SYSTEMS INC. 04015630981052

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown