BEUDAMED
    FDA Adverse Event Other Summary report: N

    THINPREP IMAGING SYSTEM

    MDR report key: 1686572 · Received May 12, 2010

    Report

    Report Number
    1222780-2010-00085
    Event Type
    Other
    Date Received
    May 12, 2010
    Date of Event
    April 13, 2010
    Report Date
    April 13, 2010
    Manufacturer
    HOLOGIC INC.
    Product Code
    MKQ
    PMA / PMN Number
    P950039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POSSIBLE FALSE NEGATIVE. ABNORMAL CELLS FOUND OUTSIDE 22 FIELDS OF VIEW. NO TRIGGER CELLS PRESENT TO PROMPT A FULL SCAN OF THE SLIDE. NO DELAY IN PT DIAGNOSIS AS THE ABNORMAL CELLS WERE FOUND DURING ROUTINE QC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other