BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLIENT

    MDR report key: 1053399 · Received May 27, 2008

    Report

    Report Number
    1222780-2008-00070
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 27, 2008
    Manufacturer
    CYTYC CORP., A FAMILY OF HOLOGIC COMPANIES
    Product Code
    KET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE BEING EVALUATED.

    Description of Event or Problem · 1

    FALSE NEGATIVE ON IN VITRO DIAGNOSTIC DEVICE: CUSTOMER REPORTED NO DIAGNOSTIC MATERIAL ON CELLIENT CELL BLOCKS. THE CELL BLOCK WAS MALIGNANT ON TRADITIONAL CELL BLOCK AND THIN PREP NON GYNECOLOGICAL INSTRUMENT, BUT THE CELLIENT BLOCKS HAD NOT DIAGNOSTIC MATERIAL. CUSTOMER'S EMAIL STATED THAT THEY HAD ONE SPECIMEN IN PARTICULAR THAT HAD TUMOR CELLS ALL OVER ON THE THIN PREP INSTRUMENT, BUT NOTHING ON THE CELLIENT. THE EMAIL ALSO STATED "WE ARE PROCESSING THE CELLIENT. THE EMAIL ALSO STATED "WE ARE PROCESSING THE CELLINET BLOCK FIRST AND THEN THE THINPREP USING THE SAME VIAL TO GET MAXIMUM YIELD ON THE CELLIENT. WHEN I PULLED THE VIAL IN THIS CASE, THERE WAS A LOT OF MATERIAL IN THE PRESERVCYT VIAL, BUT INSTEAD OF MAKING A CELLIENT WE DID A CONVENTIONAL SO WE WOULD NOT LOSE THE SPECIMEN WE HAD. THE CONVENTIONAL HAD GROUPS OF TUMOR CELLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELLIENT TISSUE PROCESSING EQUIPMENT KET CYTYC CORP., A FAMILY OF HOLOGIC COMPANIES 71663-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other