BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THINPREP SYSTEM

    MDR report key: 186194 · Received September 3, 1998

    Report

    Report Number
    1222780-1998-00003
    Event Type
    Malfunction
    Date Received
    September 3, 1998
    Date of Event
    February 20, 1998
    Report Date
    September 2, 1998
    Manufacturer
    CYTYC CORP.
    Product Code
    IFB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT RECEIVED A PAP TEST (TYPE UNKNOWN) ON 12/24/97, WHICH WAS CLASSIFIED AS "AGUS". THE PRIMARY MEDICAL DOCTOR REFERRED THE PATIENT TO THE OB/GYN WHO REPORTED THIS ADVERSE EVENT TO CYTYC. THE OB/GYN REQUESTED A THINPREP PAP TEST WHICH WAS PERFORMED ON 1/19/98. THE DIAGNOSIS WAS DEEMED TO BE CLASS II REACTIVE REPAIRATIVE CHANGES. THE PATIENT WAS CALLED BACK IN BY THE OB/GYN AND A BIOPSY WAS PERFORMED ON 1/29/98 BECAUSE THE CERVIX WAS BLEEDING ON TOUCH. THE BIOPSY REVEALED AN INVASIVE, POORLY-DIFFERENTIATED, SQUAMOUS CARCINOMA. RADICAL SURGERY WAS PERFORMED. ALL INDICATIONS, BASED ON CYTYC'S INVESTIGATION INTO THIS ISSUE, ARE THAT THE THINPREP SYSTEM DID PERFORM AS INTENDED AND THAT THERE IS NO INFORMATION THAT "REASONABLY SUGGESTS" THAT IT MALFUNCTIONED. CYTYC CORPORATION DOES NOT BELIEVE THAT THE INCIDENT REPORTED BY THE REPORTING OB/GYN IS SUFFICIENT TO INDICATE THAT THE THINPREP SYSTEM FAILED TO PERFORM PER ITS INTENDED DESIGN. DUE TO THE FACT, HOWEVER, THAT CYTYC CANNOT, WITHOUT CERTAINTY, DETERMINE THAT THE INSTRUMENT DID PERFORM CORRECTLY, A DECISION HAS BEEN MADE TO ISSUE A MDR TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINPREP SYSTEM CYTOLOGY SLIDE PREPARATION DEVICE IFB CYTYC CORP. TP-2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention