BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLESTIS

    MDR report key: 5408497 · Received February 3, 2016

    Report

    Report Number
    1122376-2016-00007
    Event Type
    Malfunction
    Date Received
    February 3, 2016
    Date of Event
    January 10, 2014
    Report Date
    February 2, 2016
    Manufacturer
    CELLESTIS INC.
    Product Code
    NCD
    UDI-DI
    04053228002109
    PMA / PMN Number
    P010033
    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)(4). DUE TO THE SIMILARITY TO A US PRODUCT, IN AN ABUNDANCE OF CAUTION, QIAGEN IS FILING A REPORT.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT RECEIVED STATING THAT THE RATIOS OF POSITIVE AND GRAY ZONES WERE HIGH IN THE MEDICAL CHECKUPS FOR 30 HEALTHCARE WORKERS AND 42 INPATIENTS. SIMILAR CASES WERE SEEN IN THE SAME LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65411 CELLESTIS QUANTIFERON-TB GOLD NCD CELLESTIS INC. A1210004 04053228002109

    Patients

    Seq Age Sex Outcome Treatment
    1