BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDEPREP PLUS CYTOLOGY CENTRIFUGE

    MDR report key: 2940505 · Received December 19, 2012

    Report

    Report Number
    1721649-2012-00003
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    SEPARATION TECHNOLOGY, INC.
    Product Code
    JQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE REPORT FROM THE CUSTOMER INVOLVES A CYTOCENTRIFUGE CALLED A SLIDEPREP PLUS, MANUFACTURED BY SEPARATION TECHNOLOGY, INC. THE CUSTOMER STATES, "AFTER THE CYCLE IS RUN AND THE CARTRIDGE WITH THE SAMPLES IS PULLED OUT AND EMPTIED, WHEN THE CARTRIDGE IS PUT BACK IN THE UNIT, IT STARTS TO SPIN WITH THE LID OPEN. THE DISPLAY SHOWS LID OPEN." THE CUSTOMER IS ALLEGING THAT THE SLIDEPREP PLUS BEGAN TO SPIN WITH THE LID OPEN WHILE THE TECH WAS PLACING THE BOWL ASSEMBLY IN THE DEVICE. THE CUSTOMER IS RETURNING THE SLIDEPREP PLUS TO SEPARATION TECHNOLOGY FOR INVESTIGATION. DEVICE IS EXPECTED TO ARRIVE BY (B)(6) 2012. A SUPPLEMENTAL REPORT SHALL BE SUBMITTED WITH THE RESULTS OF THE ANALYSIS OF THE SLIDEPREP PLUS. NO PTS WERE AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIDEPREP PLUS CYTOLOGY CENTRIFUGE SLIDEPREP PLUS JQC SEPARATION TECHNOLOGY, INC. 100-500 036

    Patients

    Seq Age Sex Outcome Treatment
    1