BEUDAMED
    FDA Adverse Event Summary report: N

    THINPREP 2000 PROCESSOR

    MDR report key: 5632643 · Received May 4, 2016

    Report

    Report Number
    1222780-2016-00109
    Date Received
    May 4, 2016
    Report Date
    May 3, 2016
    Manufacturer
    HOLOGIC, INC
    Product Code
    MKQ
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER IN BELGIUM REPORTED AN INSTANCE OF THEIR THINPREP 5000 PROCESSOR PRODUCING ERROR CODE SE 90 00. ERROR OCCURRED 2 TIMES. HOLOGIC'S TECHNICAL SERVICE REQUESTED CUSTOMER TO RUN A PNEUMATIC TEST; TEST WAS SUCCESSFUL AND WAS ABLE TO PROCESS TWO URINE SAMPLES WHILE ON THE PHONE WITHOUT ANY ISSUES. CUSTOMER REQUESTED HOLOGIC FIELD SERVICE ENGINEER (FSE) TO BE DISPATCHED TO INVESTIGATE. INSTRUMENT OPERATIONAL. FSE WAS DISPATCHED. CUSTOMER CALLED BACK AND INFORMED (B)(4) THAT INSTRUMENT IS NOW DOWN. PATIENT SAMPLE WAS LOST AND WILL HAVE TO RECALL A PATIENT FOR ADDITIONAL SAMPLE COLLECTION. FSE CONFIRMED AND REPRODUCED ERROR. REPLACED THE FOLLOWING PARTS PER TECHNICAL DOCUMENTATION TO RESOLVE THE ERROR. QTO VALVE. RAN PNEUMATIC TEST AND BLANK SAMPLES. INSTRUMENT OPERATIONAL. ALTHOUGH THE INSTRUMENT PRODUCED AN ERROR CODE DURING THIS INCIDENT, THIS IS A REPORTABLE EVENT SINCE A 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
    287344 THINPREP 2000 PROCESSOR THINPREP 2000 PROCESSOR MKQ HOLOGIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other