BEUDAMED
    FDA Adverse Event Other Summary report: N

    THIN PREP IMAGING SYSTEM

    MDR report key: 1932242 · Received December 14, 2010

    Report

    Report Number
    1222780-2010-00204
    Event Type
    Other
    Date Received
    December 14, 2010
    Date of Event
    November 17, 2010
    Report Date
    December 14, 2010
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MNM
    PMA / PMN Number
    P020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ABNORMAL CELLS FOUND OUTSIDE 22 FIELDS OF VIEW (FOV). NO TRIGGER CELLS PRESENT WITHIN 22 FOV TO PROMPT A FULL SCAN OF THE SLIDE. NO DELAY IN PT DIAGNOSIS AS THE ABNORMAL CELLS WERE FOUND DURING QC. SITE WILL BE MONITORED TO DETERMINE IF EXPECTED OCCURRENCES (AS DETERMINED BY THE PIVOTAL STUDY) ARE EXCEEDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other