BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYSIS TELVYSION 9P SPECTRUMGREEN PROBE

    MDR report key: 2802786 · Received October 24, 2012

    Report

    Report Number
    3005248192-2012-00024
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    MVU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CERTIFICATE OF ANALYSIS FOR THE VYSIS TELVYSION 9P SPECTRUMGREEN PROBE, THE HYBRIDIZATION BUFFER IS CLASSIFIED AS TOXIC AND AN IRRITANT. IT IS POSSIBLE FOR USERS TO BE CUT OR HAVE THEIR GLOVES TORN BY BROKEN VIALS, EXPOSING THEM TO THE VIAL CONTENTS AND THE BIOHAZARDOUS LAB ENVIRONMENT.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) RECEIVED BROKEN PROBE AND HYBRIDIZATION BUFFER VIALS IN THE VYSIS TELVYSION 9P SPECTRUMGREEN PROBE KIT. THERE WAS NO DAMAGE TO THE EXTERNAL PACKAGING. THE END USER WAS NOT HURT SINCE THE BROKEN PIECES WERE CONTAINED IN THE PLASTIC BAG AND WAS NOT EXPOSED TO THE CONTENTS OF THE VIALS BECAUSE THERE WAS NO LEAKAGE FROM THE PLASTIC BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VYSIS TELVYSION 9P SPECTRUMGREEN PROBE ANALYTE SPECIFIC REAGENTS MVU ABBOTT MOLECULAR, INC. 437582

    Patients

    Seq Age Sex Outcome Treatment
    1