BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLESTIS

    MDR report key: 5408534 · Received February 3, 2016

    Report

    Report Number
    1122376-2016-00009
    Event Type
    Malfunction
    Date Received
    February 3, 2016
    Date of Event
    April 3, 2013
    Report Date
    February 2, 2016
    Manufacturer
    CELLESTIS, INC.
    Product Code
    NCD
    UDI-DI
    04053228002109
    PMA / PMN Number
    P01003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A CAPA INVESTIGATION, IT WAS DETERMINED THAT COMPLAINT NUMBER (B)(4) IS RELATED TO A FOREIGN RECALL OF A PRODUCT ONLY AVAILABLE IN (B)94). DUE TO THE SIMILARITY TO A U.S PRODUCT, IN AN ABUNDANCE OF CAUTION, QIAGEN IS FILING A REPORT.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT RECEIVED STATING HIGH RATE OF POSITIVE AND GREY-ZONE RESULTS FOR RECRUIT TB SCREENING TESTS SEEN AT 2 SITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65413 CELLESTIS QUANTIFERON TB GOLD NCD CELLESTIS, INC. A1210004 04053228002109

    Patients

    Seq Age Sex Outcome Treatment
    1