BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTIFERONQ

    MDR report key: 3057646 · Received April 9, 2013

    Report

    Report Number
    3003964343-2013-00002
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    February 18, 2013
    Report Date
    April 8, 2013
    Manufacturer
    CELLESTIS LIMITED
    Product Code
    NCD
    PMA / PMN Number
    P010033
    Removal / Correction Number
    3003964343-01/28/13-001R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY HAS EVALUATED THIS EVENT AND HAS DETERMINED THAT IT IS NOT AN MDR REPORTABLE EVENT PER 21 CFR SECTION 803.50 (A). HOWEVER, THE COMPANY HAS DECIDED TO SUBMIT THIS MDR FOR INFORMATION PURPOSES IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803. THE COMPANY WILL SUPPLEMENT THIS MDR WITH ADDITIONAL INFORMATION, AS NECESSARY. BASED ON THE INFORMATION PROVIDED IT IS NOT CLEAR THAT THE PT WAS TESTED FOR TB INFECTION USING MATERIAL FROM CELLESTIS WHICH WAS RECALLED BY THE FIRM ((B)(4)), NOR IS IT EVIDENT THAT THE POSITIVE RESULT WAS FALSE. IF THE RECALLED LOT OF (B)(6) TUBES WAS INDEED USED, AND A (B)(6) RESULT WAS THE OUTPUT, THE PRODUCT INSTRUCTIONS FOR USE ADVISE THE PHYSICIAN TO REPEAT THE TEST FOR CONFIRMATION, AND IN GENERAL THE RESULTS OF THE SCREENING TEST ARE TO BE TAKEN INTO CONSIDERATION WITH THE PT'S EPIDEMIOLOGICAL HISTORY, CURRENT MEDICAL STATUS AND RESULTS OF OTHER DIAGNOSTIC EVALUATIONS. THE ALLEGED PROBLEMS ARE REPORTED TO BE THE OUTCOMES OF COMPLICATIONS RELATED TO THE (B)(6) THERAPY.

    Additional Manufacturer Narrative · 1

    THIS UPDATE IS TO PROVIDE THE DATE.

    Description of Event or Problem · 1

    THE PT'S LAWYER ALLEGES THAT (B)(6) WAS TESTED AND FOUND TO BE (B)(6) FOR (B)(6) BASED ON THE USE OF A CELLESTIS (B)(6) TEST. THE ASSUMPTION IS THE TEST WAS PERFORMED ON A LOT OF (B)(6) TUBES WHICH WAS RECALLED BY THE FIRM ((B)(4)). AS A CONSEQUENCE OF THE DIAGNOSIS OF (B)(6) FOR (B)(6) THE PT WAS PRESCRIBED THERAPY OF (B)(6) AND THIS ALLEGEDLY CAUSED "FATIGUE, CHRONIC HEADACHES, COGNITIVE DIFFICULTIES, GENERAL MYALGIAS AND TO SOME DEGREE, SWELLING AND NUMBNESS IN HER HANDS." THESE COMPLICATIONS ALLEGEDLY RESULTED IN THE PT LOSING EMPLOYMENT, AND ENCOUNTERING MARITAL AND FAMILY DIFFICULTIES. THE REPORTED DATE OF THE INCIDENT IS APPROXIMATELY (B)(6) 2012.

    Description of Event or Problem · 1

    THE PATIENT'S LAWYER ALLEGES THAT BK WAS TESTED AND FOUND TO BE POSITIVE FOR (B)(6) BASED ON THE USE OF A CELLESTIS QUANTIFERON (B)(6) GOLD TEST. THE ASSUMPTION IS THE TEST WAS PERFORMED ON A LOT OF (B)(6) TUBES WHICH WAS RECALLED BY THE FIRM (REFERENCE (B)(4)). AS A CONSEQUENCE OF THE DIAGNOSIS OF POSITIVE FOR (B)(6) THE PATIENT WAS PRESCRIBED THERAPY OF ISONIAZID AND THIS ALLEGEDLY CAUSED "FATIGUE, CHRONIC HEADACHES, COGNITIVE DIFFICULTIES, GENERAL MYALGIAS AND TO SOME DEGREE, SWELLING AND NUMBNESS IN HER HANDS." THESE COMPLICATIONS ALLEGEDLY RESULTED IN THE PATIENT LOSING EMPLOYMENT, AND ENCOUNTERING MARITAL AND FAMILY DIFFICULTIES. THE REPORTED DATE OF THE INCIDENT IS APPROXIMATELY (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147845 QUANTIFERONQ QUANTIFERON TB GOLD NCD CELLESTIS LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR