BEUDAMED
    FDA Adverse Event Other Summary report: N

    THINPREP PROCESSOR, MODEL TP 3000

    MDR report key: 1890813 · Received October 26, 2010

    Report

    Report Number
    1222780-2010-00180
    Event Type
    Other
    Date Received
    October 26, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MKQ
    PMA / PMN Number
    P950039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POTENTIAL COMPROMISE WITH DIAGNOSIS. LAB HAS BEEN SEEING SPORADIC AIR DRYING ARTIFACT OVER THE LAST 1.5 YEARS. THE APPEARANCE OF THE ARTIFACT OCCURS IN SEQUENTIAL CLUSTERS OF 5-10 SLIDES. SEVERAL CASES WERE SO SEVERE THAT THEY COULD NOT BE USED FOR DIAGNOSIS. NEW SLIDES HAD TO BE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINPREP PROCESSOR, MODEL TP 3000 PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTO MKQ HOLOGIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other