BEUDAMED
    FDA Adverse Event Summary report: N

    THINPREP 2000 PROCESSOR

    MDR report key: 5384212 · Received January 21, 2016

    Report

    Report Number
    1222780-2016-00018
    Date Received
    January 21, 2016
    Report Date
    January 21, 2016
    Manufacturer
    HOLOGIC, INC
    Product Code
    MKQ
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER IN THE US REPORTED ERROR CODES SE 45 NN ON THEIR THINPREP 2000 PROCESSOR. HOLOGIC FIELD SERVICE ENGINEER (FSE) INSTRUCTED THE CUSTOMER TO CLEAN THE CAP SEAL PORTS AND CHECK THE QTO VALVE TUBING. CUSTOMER CALLED LATER TO REPORT MULTIPLE PROCESS CANCELLED EVACUATION FAILURES AND REPORTED ERROR CODES SE 45 AND SE 87. CUSTOMER CLEANED THE CAP SEAL PORTS AND REBOOTED THE INSTRUMENT AND THAT 7 OUT OF 20 HAVE FAILED. CUSTOMER AND HOLOGIC TECHNICAL SERVICE AGREED TO PUT THE DISPATCH ON HOLD AND SEND OUT A DIFFERENT LOT OF FILTERS. CUSTOMER RECEIVED REPLACEMENT FILTERS. INSTRUMENT FULLY OPERATIONAL. JAN 21, 2016: FURTHER INVESTIGATION OF THIS INCIDENT REVEALED PATIENT(S) NEEDED TO BE RECALLED FOR ADDITIONAL SAMPLE COLLECTION. ALTHOUGH THE INSTRUMENT PRODUCED AN ERROR CODE DURING THIS INCIDENT, THIS IS A REPORTABLE EVENT SINCE 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
    43083 THINPREP 2000 PROCESSOR THINPREP 2000 PROCESSOR MKQ HOLOGIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other