BEUDAMED
    FDA Adverse Event Other Summary report: N

    THINPREP IMAGING SYSTEM

    MDR report key: 1731410 · Received June 17, 2010

    Report

    Report Number
    1222780-2010-00094
    Event Type
    Other
    Date Received
    June 17, 2010
    Date of Event
    June 9, 2010
    Report Date
    June 9, 2010
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MNM
    PMA / PMN Number
    P020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ABNORMAL CELLS 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 PATIENT 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 MNM HOLOGIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other