BEUDAMED
    FDA Adverse Event Other Summary report: N

    THINPREP IMAGING SYSTEM

    MDR report key: 2935849 · Received January 22, 2013

    Report

    Report Number
    1222780-2013-00017
    Event Type
    Other
    Date Received
    January 22, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 23, 2012
    Manufacturer
    HOLOGIC INC
    Product Code
    MNM
    PMA / PMN Number
    P020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINT ISSUE ID # (B)(4). POSSIBLE FALSE NEGATIVE. CUSTOMER AND AUTHOR OF (B)(4) NOT IDENTIFIED. IMAGER AND THINPREP FUNCTIONED AS INTENDED AND MET THEIR PERFORMANCE SPECIFICATIONS. THE PAP TEST IS DESIGNED TO SCREEN FOR CHANGES IN THE CELLS OF THE CERVIX AND HOLOGIC'S IMAGING SYSTEM IS DESIGNED TO ASSIST IN PRIMARY CERVICAL CANCER SCREENING OF THINPREP PAP TEST SLIDES. THE IMAGER IS NOT DESIGNED TO SPECIFICALLY IDENTIFY CELL TYPES OUTSIDE OF THE UTERINE CERVIX AND BECAUSE THE DESCRIPTION OF THESE EXTRA CERVICAL CELL CLUSTERS IN QUESTION IS "PLAIN AND OBVIOUS", THE IMAGER MOST LIKELY WOULD NOT HAVE IDENTIFIED THEM AS OBJECTS OF INTEREST FOR THE CYTOTECHNOLOGIST TO REVIEW. AS INDICATED IN HOLOGIC'S MARKETING LITERATURE AND INSTRUCTIONS FOR USE BOTH IMAGER AND CYTOTECHNOLOGIST REVIEW ARE NEEDED TO ENSURE ACCURATE RESULTS. HOLOGIC BELIEVES THAT A VAST MAJORITY OF ALL STUDIES PUBLISHED SUPPORT ITS THINPREP AND IMAGER CLAIMS AND THAT ITS MARKETING CLAIMS ARE CONSISTENT WITH ITS PACKAGING INSERT AND PIVOTAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31627 THINPREP IMAGING SYSTEM AUTOMATED MICROSCOPE FOR CYTOLOGY MNM HOLOGIC INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other