BEUDAMED
    FDA Adverse Event Summary report: N

    THINPREP 2000 PROCESSOR

    MDR report key: 3805871 · Received April 30, 2014

    Report

    Report Number
    1222780-2014-00075
    Date Received
    April 30, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MKQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POSSIBLE FALSE NEGATIVE INCIDENTS HAVE OCCURRED, HOWEVER, NO MISDIAGNOSIS HAS OCCURRED. THE CHIEF PATHOLOGIST FROM THE PUBLIC HEALTH LABORATORY SERVICES IN (B)(6) REPORTED THAT THE FIRST SPUTUM SLIDE PROCESSED WITH THE THIN PREP 2000 PROCESSOR WAS NEGATIVE WITH LOW CELLULARITY. THE PT HAS RECENT HISTORY OF ABNORMALITY, SO SHE ASKED THE LAB TECHNICIAN TO PREPARE THE SECOND SLIDE FROM THE SAME VIAL WITHOUT ANY TREATMENT AND SHE FOUND MORE THAN 5 CLUSTERS OF ABNORMAL CELLS WITH CONFIRMED DIAGNOSIS OF ADENOCARCINOMA (NON-GYN CYTOLOGY). AFTER 2 WEEKS, SHE FOUND ANOTHER CASE OF SPUTUM WITH SIMILAR DISCREPANCY. HOWEVER FOR THIS CASE, THE FIRST SLIDE HAS SATISFACTORY CELLULARITY. SHE ASKED FOR THE PREPARATION OF SECOND SLIDE FROM THE SAME VIAL WITHOUT TREATMENT BECAUSE THE PT AGAIN HAS RECENT HISTORY OF ABNORMALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259000 THINPREP 2000 PROCESSOR THINPREP 2000 PROCESSOR MKQ HOLOGIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other