BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBECHEK UROVYSION BLADDER CANCER KIT CONTROL SLIDES

    MDR report key: 2698867 · Received January 16, 2012

    Report

    Report Number
    3005248192-2012-00004
    Event Type
    Malfunction
    Date Received
    January 16, 2012
    Date of Event
    December 20, 2011
    Report Date
    December 20, 2011
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    MMW
    PMA / PMN Number
    P030052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING NARRATIVE IS CONTAINED IN THE PRODUCT PACKAGE INSERT: "THE PROBECHEK CONTROLS AND ALL OTHER FRESH OR FIXED SPECIMENS SHOULD BE HANDLED AS IF CAPABLE OF TRANSMITTING INFECTIOUS AGENTS. DISPOSE OF WITH PROPER PRECAUTIONS. BECAUSE IT IS OFTEN IMPOSSIBLE TO KNOW WHICH MIGHT BE INFECTIOUS, ALL SPECIMENS ARE TO BE TREATED WITH UNIVERSAL PRECAUTIONS. GUIDELINES FOR SPECIMEN HANDLING ARE AVAILABLE FROM THE UNITED STATES CENTERS FOR DISEASE CONTROL AND PREVENTION. MATERIAL SAFETY DATA SHEETS (MSDS) ON ALL MATERIALS SUPPLIED IN THE PROBECHEK CONTROLS ARE AVAILABLE FROM THE ABBOTT MOLECULAR TECHNICAL SERVICE DEPARTMENT. AVOID CONTACT OF PROBECHEK SLIDES WITH SKIN AND MUCOUS MEMBRANES."

    Description of Event or Problem · 1

    THE PROBECHEK UROVYSION CONTROL SLIDES ARE NON-HYBRIDIZED SLIDES PREPARED WITH CULTURED NORMAL MALE LYMPHOBLAST CELLS AND CULTURED BLADDER CANCER CELL LINES. EACH CONTROL SLIDE CONSISTS OF TWO SEPARATE TARGET AREAS IN WHICH EACH OF THE DIFFERENT CELL TYPES HAVE BEEN APPLIED. THE CELL LINES ARE HARVESTED, FIXED IN SUSPENSION MEDIUM, AND APPLIED TO THE GLASS MICROSCOPE SLIDES IN A METHOD OPTIMAL FOR FISH (FLUORESCENCE IN SITU HYBRIDIZATION). A CUSTOMER REPORTED THAT THE SLIDES ARRIVED BROKEN IN A PROBECHEK UROVYSION BLADDER KIT CONTROL SLIDES PACKAGE. THERE WAS NO DAMAGE TO THE EXTERIOR SHIPPING BOX. THE PLASTIC SLIDE BOX WAS CRACKED AND THE BROKEN SLIDES WERE INSIDE THE PACKAGE. THE PLASTIC WRAPPING OF THE PACKAGE WAS INTACT AND THE BROKEN SLIDE PARTS WERE CONTAINED IN THE PLASTIC WRAPPING. THERE WAS NO EXPOSURE TO OR INJURY CAUSED BY THE BROKEN SLIDES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROBECHEK UROVYSION BLADDER CANCER KIT CONTROL SLIDES MICROSCOPIC CONTROL SLIDES USED IN FISH TESTING MMW ABBOTT MOLECULAR, INC. 435930

    Patients

    Seq Age Sex Outcome Treatment
    1