BEUDAMED
    FDA Adverse Event Other Summary report: N

    THINPREP IMAGING SYSTEM

    MDR report key: 1619867 · Received February 25, 2010

    Report

    Report Number
    1222780-2010-00029
    Event Type
    Other
    Date Received
    February 25, 2010
    Date of Event
    January 28, 2010
    Report Date
    January 28, 2010
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MNM
    PMA / PMN Number
    PMA020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POSSIBLE FALSE NEGATIVE. ABNORMAL CELLS FOUND OUTSIDE 22 FIELDS OF VIEW (FOV). NO TRIGGER CELLS PRESENT WITHIN 22 FOV TO PROMPT A FULL SCAN OF THE SLIDE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other