BEUDAMED
    FDA Adverse Event Other Summary report: N

    THINPREP IMAGING SYSTEM

    MDR report key: 1592106 · Received January 29, 2010

    Report

    Report Number
    1222780-2010-00016
    Event Type
    Other
    Date Received
    January 29, 2010
    Date of Event
    January 6, 2010
    Report Date
    January 6, 2010
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MNM
    PMA / PMN Number
    P020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ABNORMAL CELLS FOUND OUTSIDE OF 22 FIELDS OF VIEW (FOV). NO TRIGGER CELLS WERE PRESENT WITHIN 22 FOV TO PROMPT AN AUTOSCAN OF THE ENTIRE SLIDE. NO DELAY IN PT DIAGNOSIS AS THE CELLS WERE FOUND DURING QC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINPREP IMAGING SYSTEM MICROSCOPE SLIDE FOR CYTOLOGY MNM HOLOGIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other