BEUDAMED
    FDA Adverse Event Other Summary report: N

    THINPREP IMAGING SYSTEM

    MDR report key: 3289971 · Received August 7, 2013

    Report

    Report Number
    1222780-2013-00147
    Event Type
    Other
    Date Received
    August 7, 2013
    Date of Event
    July 23, 2013
    Report Date
    July 30, 2013
    Manufacturer
    HOLOGIC INC
    Product Code
    MNM
    PMA / PMN Number
    P020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POSSIBLE FALSE NEGATIVE. NO TRIGGERS PRESENT. ONE OBJECT OF INTEREST OUTSIDE CELL SPOT. INSTRUMENT OPERATIONAL. PERFORMED ALL REQUIRED SETUPS PER TECHNICAL DOCUMENTATION. CLEANED OPTIC PATH. RAN VERIFICATION SLIDE AND SHORT BATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371581 THINPREP IMAGING SYSTEM AUTOMATED MICROSCOPE FOR CYTOLOGY MNM HOLOGIC INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other