BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLESTIS

    MDR report key: 5408486 · Received February 3, 2016

    Report

    Report Number
    1122376-2016-00004
    Event Type
    Malfunction
    Date Received
    February 3, 2016
    Date of Event
    August 8, 2012
    Report Date
    February 2, 2016
    Manufacturer
    CELLESTIS INC
    Product Code
    NCD
    UDI-DI
    04053228002109
    PMA / PMN Number
    P010033
    Removal / Correction Number
    3003964343-01/28/13-001R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT OF A CAPA INVESTIGATION, HISTORICAL COMPLAINTS WERE FOUND THAT WERE IDENTIFIED AS REQUIRING A MEDWATCH REPORT. THE COMPANY HAS DECIDED TO SUBMIT THIS MDR FOR INFORMATION PURPOSES TO ENSURE FULL COMPLIANCE WITH 21CFR PART 803. CELLESTIS FILED NOTIFICATION OF THEIR VOLUNTARY RECALL THROUGH THE REGIONAL FDA DISTRICT RECALL OFFICE ON 16OCT2012. CLOSURE OF THE RECALL BY THE FDA WAS RECEIVED 25APR2013.

    Description of Event or Problem · 1

    CELLESTIS CUSTOMER COMPLAINT (B)(4) RECEIVED STATING THAT A PATIENT TESTED POSITIVE AND UPON RE-TEST ONE MONTH LATER WAS NEGATIVE. THE CUSTOMER IS CONCERNED THAT THEIR GENERAL FALSE POSITIVE RATE IS AT (B)(6) IN ACCORDANCE WITH THEIR RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65347 CELLESTIS QUANTIFERON TB GOLD NCD CELLESTIS INC A111103N 04053228002109

    Patients

    Seq Age Sex Outcome Treatment
    1