BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TOTALYS SLIDEPREP

    MDR report key: 17651680 · Received August 30, 2023

    Report

    Report Number
    3008007472-2023-00025
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Date of Event
    August 2, 2023
    Report Date
    October 27, 2023
    Manufacturer
    TRIPATH IMAGING, INC
    Product Code
    MKQ
    UDI-DI
    00382904913465
    PMA / PMN Number
    P970018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: COMPLAINT REPORTS CONTAMINATION ON SLIDEPREP (CATALOG NUMBER 491346) SERIAL NUMBER (B)(6). COMPLAINT ALLEGES QUAD BUNDLES TOUCHED THE SLIDES AND POSSIBLE CONTAMINATION. SERVICE ADJUSTED THE HEIGHT OF THE QUAD ARM, AND NO CONTAMINATION REPORTED. POST INTERVENTION THE INSTRUMENT WAS LEFT OPERATING NORMALLY. ROOT CAUSE ATTRIBUTED TO QUAD ARM HEIGHT. THIS COMPLAINT IS A CONFIRMED FAILURE OF THE INSTRUMENT BASED ON THE SERVICE INVESTIGATION. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT SERIAL NUMBER, (B)(6) IS NOT REQUIRED BECAUSE THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION AND HAS CHANGED CONFIGURATION SINCE RELEASE FROM MANUFACTURING DUE TO SERVICE REPAIRS/PMS. DEVICE WAS INSTALLED ON (B)(6)2016. SERVICE HISTORY REVIEW WAS PERFORMED FOR THE INSTRUMENT (B)(6), AND NO ADDITIONAL WORK ORDERS WERE OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED. REVIEW OF RISK MANAGEMENT FILES CONFIRMS THERE ARE NO NEW OR MODIFIED RISKS ASSOCIATED WITH THIS FAILURE MODE. THERE IS NO CORRECTIVE AND PREVENTATIVE ACTION PLAN IN PLACE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD TOTALYS SLIDEPREP, THERE WAS CROSS-CONTAMINATION. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE WAD TOUCHED THE GLASS, AND SOME PIECES WERE SUSPECTED OF BEING CONTAMINATED. WAS THE CONTAMINATION NOTICED PRIOR TO ANY RESULTS BEING GENERATED? >> YES. NO PATIENT IMPACT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD TOTALYS SLIDEPREP, THERE WAS CROSS-CONTAMINATION. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE WAD TOUCHED THE GLASS, AND SOME PIECES WERE SUSPECTED OF BEING CONTAMINATED. WAS THE CONTAMINATION NOTICED PRIOR TO ANY RESULTS BEING GENERATED? >> YES. NO PATIENT IMPACT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315002 BD TOTALYS SLIDEPREP PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED MKQ TRIPATH IMAGING, INC 00382904913465

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown