BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENCHMARK ULTRA

    MDR report key: 16351376 · Received February 10, 2023

    Report

    Report Number
    2028492-2023-00014
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    January 5, 2023
    Report Date
    March 29, 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
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO SHARE THE CONCLUSIONS OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THROUGHOUT THE INVESTIGATION, A SOFTWARE MALFUNCTION COULD NOT BE FOUND. THE RUN REPORTS DID NOT SHOW ANY ANOMALIES. A TEMPORARY DISPENSER PLUG OR LEAKY DISPENSER COULD NOT BE RULED OUT AS CAUSAL FACTORS FOR THE EVENT. PREPARING, HANDLING AND STORAGE INSTRUCTIONS FOR INLINE DISPENSERS DIRECT THE OPERATOR TO INSPECT PRIME AND NOZZLE TIP BEFORE EACH USE. CORRECTED B3 - DATE OF EVENT FROM 1/4/2023 TO (B)(6) 2023. UPDATED B5 TO REFLECT THAT THE EXPECTED STAINING OCCURRED BUT IN ADDITION, UNEXPECTED GLYCOPHORIN STAINING WAS OBSERVED ON THE TWO SLIDES. UPDATED THE RESTAINING DATE OF THE 2 SLIDES FROM 1/10/2023 TO (B)(6) 2023.

    Description of Event or Problem · 0

    A CUSTOMER FROM TURKEY ALLEGED INCORRECT STAINING FOR TWO SLIDES USING THE BENCHMARK ULTRA INSTRUMENT, WHICH OCCURRED ON (B)(6) 2023. ONE SLIDE WAS INTENDED FOR CD61 STAINING AND ONE SLIDE WAS INTENDED FOR MPO STAINING. HOWEVER, EACH OF THESE TWO SLIDES WERE STAINED WITH GLYCOPHORIN. THE CUSTOMER RESTAINED THE SLIDES ON 10 JAN 2023 ON THE SAME INSTRUMENT AND BOTH WERE STAINED APPROPRIATELY AND AS EXPECTED. THE RESULTS OF THE ALLEGED INCORRECT STAINED SLIDES WERE NOT REPORTED. NO HARM IS ALLEGED.

    Description of Event or Problem · 0

    ONE SLIDE WAS INTENDED FOR CD61 STAINING AND ONE SLIDE WAS INTENDED FOR MPO STAINING. BOTH ALLEGED SLIDES SHOWED INTENDED STAINING BUT ALSO SHOWED UNEXPECTED GLYCOPHORIN STAINING. THE CUSTOMER RESTAINED THE SLIDES ON (B)(6) 2023 ON THE SAME INSTRUMENT AND BOTH WERE STAINED APPROPRIATELY AND AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54509 BENCHMARK ULTRA SLIDE STAINER, AUTOMATED KPA VENTANA MEDICAL SYSTEMS INC NA NA 04015630981052

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown