BEUDAMED
    FDA Adverse Event Summary report: N

    THINPREP 3000 PROCESSOR

    MDR report key: 5732118 · Received June 17, 2016

    Report

    Report Number
    1222780-2016-00146
    Date Received
    June 17, 2016
    Report Date
    June 15, 2016
    Manufacturer
    HOLOGIC, INC
    Product Code
    MKQ
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER IN THE US REPORTED AN INSTANCE OF THEIR THINPREP 3000 PROCESSOR HAVING A FIXATIVE CLOGGED WHICH WAS RESOLVED BY CLEANING NOZZLE WITH WARM WATER. HOWEVER, NOW REPORTS THE MACHINE IS SUCKING UP ALL THE SAMPLE IN THE VIAL AND NOT ABLE TO MAKE A SLIDE. ACCORDING TO CALLER, NO ERROR CODE OR MESSAGE IS PRESENT. SYSTEM IS NOT USABLE AND TAKEN OFFLINE. HOLOGIC FIELD SERVICE ENGINEER (FSE) DISPATCHED TO THE CUSTOMERS SITE. FSE FOUND EVACUATION VALVE TO BE CAUSE OF PROBLEM. REPLACED QTO VALVE AS A PRECAUTION. REPLACED FIXATIVE AIR BRUSH AND LEE VALVE FOR SLOW FLOW. ALL REPLACEMENTS AND VERIFICATIONS PERFORMED PER TECHNICAL DOCUMENTATION. RAN PNEUMATIC TEST AND BLANK SAMPLE TO VERIFY INSTRUMENT OPERATIONAL. THIS IS A REPORTABLE EVENT SINCE THE THINPREP 3000 PROCESSOR DID NOT PERFORM AS INTENDED AND THE PATIENT NEEDED TO BE RECALLED FOR ADDITIONAL SAMPLE COLLECTION, WHICH RESULTED IN A DELAY IN PATIENT DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387019 THINPREP 3000 PROCESSOR THINPREP 3000 PROCESSOR MKQ HOLOGIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other