BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINPREP IMAGING SYSTEM

    MDR report key: 3949350 · Received June 25, 2014

    Report

    Report Number
    1222780-2014-00112
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 30, 2014
    Manufacturer
    HOLOGIC INC.,
    Product Code
    MNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POSSIBLE FALSE NEGATIVE. LAB REPORTED THREE (3) CASES IN WHICH ABNORMAL CELLS FOUND OUTSIDE OF 22 FIELDS OF VIEW (FOV). NO ABNORMAL CELLS WERE PRESENT WITHIN THE 22 FOV TO PROMPT FULL AUTOSCAN OF THE SLIDE. THE ABNORMAL CELLS WERE FOUND OUTSIDE THE FOV DURING QC. SITE WILL BE MONITORED TO DETERMINE IF EXPECTED OCCURRENCES ARE EXCEEDED. HOLOGIC WILL SCHEDULE A FULL IMAGER PREP REVIEW WITH THE LABORATORY. THIS INCIDENT IS CLASSIFIED AS A RARE EVENT, WHICH IS WHERE THE CELLS IN QUESTION WOULD MATCH OUR EXPERIENCE IN THE CLINICAL TRIAL AS EVIDENCED IN TABLE 8 OF THE THINPREP IMAGING SYSTEM OPERATING SUMMARY AND CLINICAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370582 THINPREP IMAGING SYSTEM AUTOMATED MICROSCOPE FOR CYTOLOGY MNM HOLOGIC INC.,

    Patients

    Seq Age Sex Outcome Treatment
    1 Other