BEUDAMED
    FDA Adverse Event Other Summary report: N

    THINPREP IMAGING SYSTEM

    MDR report key: 3130017 · Received May 22, 2013

    Report

    Report Number
    1222780-2013-00093
    Event Type
    Other
    Date Received
    May 22, 2013
    Date of Event
    December 1, 2012
    Report Date
    May 1, 2013
    Manufacturer
    HOLOGIC
    Product Code
    MNM
    PMA / PMN Number
    P020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LAB TECH MENTIONED FINDING 25-40 MISSED LSIL OVER AN APPROX 6 MONTH TIME FRAME. CYTOLOGY APPLICATION SUPPORT SPECIALIST (CAS) WAS UNABLE TO AND WAS NOT IN A POSITION TO RESEARCH AND DETERMINE IF THERE WERE TRIGGERS IN THE 22 FIELDS OF VIEW. CUSTOMER DID NOT HAVE TIME OR RESOURCES TO TROUBLE SHOOT AT THIS TIME BUT WILL GATHER THE INFO AT A FUTURE TIME WHEN THEY ARE READY TO INVESTIGATE. SINCE THERE ARE MULTIPLE INITIATIVES NOW GOING ON IN THE LAB, CAS SUGGESTED WE REVISIT IN THE NEAR FUTURE. CAS WILL FOLLOW-UP AGAIN WITH THIS CUSTOMER WITHIN 60 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227021 THINPREP IMAGING SYSTEM AUTOMATED MICROSCOPE FOR CYTOLOGY MNM HOLOGIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other