BEUDAMED
    FDA Adverse Event Summary report: N

    THINPREP IMAGING SYSTEM

    MDR report key: 3775328 · Received April 15, 2014

    Report

    Report Number
    1222780-2014-00060
    Date Received
    April 15, 2014
    Report Date
    March 27, 2014
    Manufacturer
    HOLOGIC INC
    Product Code
    MNM
    PMA / PMN Number
    P020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NO DELAY IN PT DIAGNOSIS. CUSTOMER REPORTED A GROUP OF HSIL CELLS WERE OUTSIDE OF THE 22 FIELDS OF VIEW (FOV) AND THERE WERE NO ABNORMAL CELLS FOUND IN ANY OF THE 22 FOVS. CYTOLOGY APPLICATIONS SPECIALIST CONFIRMED THE IMAGER MISS. PT HAD PREVIOUS CASE OF HSIL; THEREFORE ,A FULL SCAN OF THE SLIDE WAS COMPLETED. CUSTOMER AGREED IMAGER OPERATED AS EXPECTED AND DID NOT WANT TO PROCEED ANY FURTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230850 THINPREP IMAGING SYSTEM AUTOMATED MICROSCOPE FOR CYTOLOGY MNM HOLOGIC INC

    Patients

    Seq Age Sex Outcome Treatment
    1