BEUDAMED
    FDA Adverse Event Other Summary report: N

    THINPREP IMAGING SYSTEM

    MDR report key: 2042216 · Received March 31, 2011

    Report

    Report Number
    1222780-2011-00069
    Event Type
    Other
    Date Received
    March 31, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 31, 2011
    Manufacturer
    HOLOGIC INC.
    Product Code
    MKQ
    PMA / PMN Number
    P020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED A COUPLE OF SLIDES WHERE NO TRIGGER CELLS WERE PRESENT DURING THE 22 FIELDS OF VIEW (FOV), BUT LSIL CELLS WERE PICKED UP ON THE MANUAL SCOPE. CAS ASKED TO REVIEW THESE POTENTIALLY DISCREPANT CASES, BUT CUSTOMER DID NOT HAVE ANY PULLED FOR VIEWING. CAS SUGGESTED THAT CUSTOMER SAVE THESE CASES MOVING FORWARD SO CAS CAN REVIEW AND COULD POSSIBLY SEND THEM TO CORPORATE FOR FURTHER RESEARCH.

    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