BEUDAMED
    FDA Adverse Event Other Summary report: N

    THINPREP IMAGING SYSTEM

    MDR report key: 1584181 · Received January 20, 2010

    Report

    Report Number
    1222780-2010-00015
    Event Type
    Other
    Date Received
    January 20, 2010
    Date of Event
    January 12, 2010
    Report Date
    January 12, 2010
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MNM
    PMA / PMN Number
    P020002
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POSSIBLE FALSE NEGATIVE. NO DELAY IN PT DIAGNOSIS. ABNORMAL CELLS FOUND OUTSIDE 22 FIELDS OF VIEW (FOV) DURING QC. CAS AGREED NO TRIGGER CELLS SEEN IN FOV TO PROMPT AN AUTOSCAN.

    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 NI Other