BEUDAMED
    FDA Adverse Event Other Summary report: N

    THINPREP IMAAGING SYSTEM

    MDR report key: 1780880 · Received July 26, 2010

    Report

    Report Number
    1222780-2010-00119
    Event Type
    Other
    Date Received
    July 26, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 16, 2010
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MNM
    PMA / PMN Number
    P020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POSSIBLE FALSE NEGATIVE. ABNORMAL CELLS FOUND OUTSIDE OF 22 FIELDS OF VIEW (FOV). NO TRIGGER CELLS PRESENT TO PROMPT A FULL SCAN OF THE SLIDE. THERE WAS NO DELAY IN PT DIAGNOSIS AS DIAGNOSTIC CELLS WERE FOUND DURING QC. THE LAB WILL NOT BE SENDING THE SLIDE IN FOR REVIEW. THIS SITE WILL BE MONITORED TO DETERMINE IF EXPECTED OCCURRENCES (AS DETERMINED BY THE PIVOTAL TRIAL) ARE EXCEEDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other