BEUDAMED
    FDA Adverse Event Other Summary report: N

    THINPREP IMAGING SYSTEM

    MDR report key: 1874244 · Received October 12, 2010

    Report

    Report Number
    1222780-2010-00165
    Event Type
    Other
    Date Received
    October 12, 2010
    Date of Event
    September 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MKQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ABNORMAL CELLS WERE FOUND OUTSIDE OF THE 22 FIELDS OF VIEW (FOV). NO TRIGGER CELLS WERE PRESENT TO PROMPT A FULL SCAN OF THE SLIDE. THERE WAS NO DELAY IN PT DIAGNOSIS AS THE DIAGNOSTIC CELLS WERE FOUND DURING QC. CUSTOMER IS NOT SENDING SLIDE TO HOLOGIC FOR REVIEW.

    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