BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENCHMARK ULTRA

    MDR report key: 16513201 · Received March 9, 2023

    Report

    Report Number
    2028492-2023-00021
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 7, 2023
    Report Date
    July 14, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE INVESTIGATION, IT WAS OBSERVED THAT THE USER DELETED ORDERS 15 TIMES ON (B)(6)2023. ONCE THE ORDER WAS DELETED, THE USID/BARCODE LABEL WAS RECYCLED. THE ISSUE WAS LIKELY CAUSED BY ANOTHER ORDER CREATED WITH THE RECYCLED USID/BARCODE LABEL. A SLIDE WITH A PREVIOUSLY PRINTED LABEL WAS THEN LOADED ONTO THE INSTRUMENT. THE PROTOCOL, SUCH AS THE HUMAN READABLE TEXT, OF THE INITIALLY PRINTED LABEL DOES NOT MATCH THE PROTOCOL ASSOCIATED WITH THE NEWLY GENERATED USID/BARCODE LABEL. THUS A SLIDE CONTAINING THE INITIAL LABEL (IF NOT DISCARDED) COULD BE STAINED WITH A PROTOCOL ORDERED FOR THE NEW USID/BARCODE LABEL. THE ISSUE WILL BE ADDRESSED IN THE UPCOMING SOFTWARE UPDATE. THERE ARE SEVERAL MITIGATING FACTORS THAT ALLOW THE DETECTABILITY OF THIS SCENARIO: THE EXPECTED STAINING PATTERN OF THE INTENDED ASSAY, THE USE OF THE SAME SLIDE AND/OR INTERNAL POSITIVE CONTROLS, COMPARISON OF THE LABEL TO THE RUN REPORT WHICH WILL SHOW A PROTOCOL MISMATCH, AND INTERPRETATION IN CONJUNCTION WITH OTHER RELEVANT CLINICAL INFORMATION AND ASSAY RESULTS. ----- DATE OF EVENT WAS UPDATED TO 2/7/2023.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ON-GOING. A SUPPLEMENTAL MDR WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. INITIAL REPORTER FACILITY NAME TRUNCATED DUE TO CHARACTER LIMIT: (B)(6).

    Description of Event or Problem · 0

    A CUSTOMER FROM GERMANY ALLEGED A STAINING ISSUE FOR ONE SLIDE USING THE BENCHMARK ULTRA INSTRUMENT. ONE SLIDE WAS INTENDED FOR PREPKIT#185, HOWEVER, AN ERROR MESSAGE APPEARED REQUESTING ANOTHER ANTIBODY (CD34 (QBEND10) FOR THIS SLIDE. THE ISSUE WAS DISCOVERED AS THE REQUESTED ANTIBODY CD34 (QBEND10) WAS NOT ON THE INSTRUMENT. NO RESULTS WERE GENERATED. NO HARM IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706356 BENCHMARK ULTRA SLIDE STAINER, AUTOMATED KPA VENTANA MEDICAL SYSTEMS INC NA NA 04015630981052

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown