BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLOGIC

    MDR report key: 1881999 · Received October 19, 2010

    Report

    Report Number
    MW5017887
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 2, 2010
    Report Date
    October 19, 2010
    Manufacturer
    HOLOGIC
    Product Code
    LEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CYTOLOGY DEPARTMENT NOTICED SEVERAL AFB POSITIVE CASES ON BRONCHIAL BRUSH SPECIMENS. THE DEPARTMENT QUESTIONED THE VALIDITY OF THE QUESTIONABLE RESULTS AND VALIDATED AGAINST PT CULTURES. SUSPECTED A CONTAMINANT IN THE HOLOGIC THIN-PREP VIAL. THIS WAS VERIFIED BY PREPARING A "BLANK" VIAL AND IT RENDERED AN "AFB POSITIVE" RESULT. DATES OF USE: (B)(4) 2010. DIAGNOSIS OR REASON FOR USE: TEST TO RULE OUT TB. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLOGIC THIN PREP VIAL LEA HOLOGIC 04068V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other