BEUDAMED
    FDA Adverse Event Other Summary report: N

    THINPREP IMAGING SYSTEM

    MDR report key: 2031890 · Received March 21, 2011

    Report

    Report Number
    1222780-2011-00048
    Event Type
    Other
    Date Received
    March 21, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 18, 2011
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MKQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NO DELAY IN PT DIAGNOSIS. CUSTOMER REPORTED DIAGNOSTIC CELLS OUTSIDE THE 22 FIELDS OF VIEW (FOV) WHICH WERE FOUND DURING QC INSPECTION. PT WAS ORIGINALLY SIGNED OFF AS NEGATIVE, THEN CHANGED TO LSIL. CUSTOMER REPORTED THE SLIDE WAS UNAVAILABLE FOR THE CAS TO REVIEW. CUSTOMER DOES NOT WANT TO F/U FURTHER.

    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 Other