BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLESTIS

    MDR report key: 5408484 · Received February 3, 2016

    Report

    Report Number
    1122376-2016-00002
    Event Type
    Malfunction
    Date Received
    February 3, 2016
    Date of Event
    July 9, 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
    SD, 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. (B)(4).

    Description of Event or Problem · 1

    CELLESTIC CUSTOMER (B)(4) RECEIVED WHERE CUSTOMER REPORTED THAT THEY DREW 5 SAMPLES ON MONDAY ((B)(6)) BEFORE TRAINING. DURING THE FIRST DAY OF TRAINING , THE SAMPLES WERE RUN AND ALL RESULTED AS POSITIVE. THEY STATED THAT THEY HAD WORKED IN MANY DIFFERENT LABS IN THE HOSPITALS AND WITH LOTS OF PATIENTS. THAT SAME DAY THE SAMPLES WERE REDRAWN PLUS AN ADDITIONAL 2 SAMPLES. THEY REPEATED AS POSITIVE ON THE SECOND DAY OF TRAINING, WITH THE ADDITIONAL 2 SAMPLES AS NEGATIVE. THE VALIDATION SAMPLES THAT WERE SUPPLIED RESULTED AS EXPECTED WITH A MIXTURE OF POSITIVES AND NEGATIVE RESULTS. THE CUSTOMER SENT THE 7 TUBES THAT WERE DRAWN FOR THE SECOND DAY OF TESTING TO THEIR LAB IN SIOUX FALLS, AND THEY CONFIRMED THE POSITIVE AND NEGATIVE RESULTS. THE CUSTOMER THEN ORDERED A NEW TUBE LOT AND REDREW THE SAME 7 SAMPLES. THEY RAN THESE SAMPLES IN THEIR LAB AND SENT THEM TO MAYO TO RUN. ALL ARE NEGATIVE. THEY ARE CONVINCED THAT IT IS THE LOT OF TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66876 CELLESTIS QUANTIFERON TB GOLD NCD CELLESTIS INC A111103N 04053228002109

    Patients

    Seq Age Sex Outcome Treatment
    1