BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTIFERON

    MDR report key: 3057623 · Received April 9, 2013

    Report

    Report Number
    3003964343-2013-00003
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    August 1, 2012
    Report Date
    April 8, 2013
    Manufacturer
    CELLESTIS LIMITED
    Product Code
    NCD
    PMA / PMN Number
    P010033
    Removal / Correction Number
    300396434-01/28/13-001R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS UPDATE IS TO PROVIDE THE DATE.

    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 (B)(6) USING MATERIAL FROM CELLESTIS WHICH WAS RECALLED BY THE FIRM (RECALL REFERENCE # 3003964343-01/28/13-001-R), (B)(6). IF THE RECALLED LOT OF (B)(6) TUBES WAS INDEED USED, AND A FALSE POSITIVE 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 REPORTED ARE THE OUTCOMES OF SUBSEQUENT TREATMENT OF THE PT USING (B)(6).

    Description of Event or Problem · 1

    THE PATIENT (DS) ALLEGES THAT TO HAVE BEEN 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)). THE PATIENT WAS BEING SCREENED FOR LATENT (B)(6) AS A HEALTH CARE STUDENT AND REQUIREMENT OF THE INSTITUTION WHERE CLINICAL ACTIVITIES ARE PART OF THE CURRICULUM. AS A CONSEQUENCE OF THE DIAGNOSIS OF (B)(6) THE PATIENT WAS PRESCRIBED THERAPY OF RIFAMPIN - 600 MG - FOR FOUR MONTHS. "THE PILLS MADE ME FEEL WEAK AT ALL TIMES, FATIGUED MORE THAN MY NORMAL STUDENT ACTIVITIES WOULD CAUSE HAVING DIFFICULTIES CONCENTRATING, FEELING FAINT, SLIGHTLY NAUSEATED THROUGHOUT THE DAY AND THE WORSE (SIC) OF THEM ALL WAS THE ITCHING I EXPERIENCED OVERNIGHT" RESULTING IN LOSS OF SLEEP. TEST RESULTS SHOWING ELEVATED LIVER ENZYMES ARE REPORTED BUT NOT INCLUDED. THERAPY WAS CONTINUED FOR APPROXIMATELY 1.5 MONTHS PRIOR TO CESSATION. NO LABORATORY DATA HAS BEEN PROVIDED AND THE REPORTED DATE OF THE INCIDENT IS (B)(6) 2012.

    Description of Event or Problem · 1

    THE PT ((B)(6)) ALLEGES THAT TO HAVE BEEN TESTED AND FOUND TO BE (B)(6) BASED ON THE USE OF (B)(6). THE ASSUMPTION IS THE TEST WAS PERFORMED ON A LOT OF (B)(6) TUBES WHICH WAS RECALLED BY THE FIRM (REFERENCE 3003964343-01/28/001-R). THE PT WAS BEING SCREENED FOR LATENT (B)(6) AS A HEALTH CARE STUDENT AND REQUIREMENT OF THE INSTITUTION WHERE CLINICAL ACTIVITIES ARE PART OF THE CURRICULUM. AS A CONSEQUENCE OF THE DIAGNOSIS OF (B)(6) THE PT WAS PRESCRIBED THERAPY (B)(6). "THE PILLS MADE ME FEEL WEAK AT ALL TIMES, FATIGUED MORE THAN MY NORMAL STUDENT ACTIVITIES WOULD CAUSE, HAVING DIFFICULTIES CONCENTRATING, FEELING FAINT, SLIGHTLY NAUSEATED THROUGHOUT THE DAY AND THE WORSE (SIC) OF THEM ALL WAS THE ITCHING I EXPERIENCED OVERNIGHT" RESULTING IN LOSS OF SLEEP. TEST RESULTS SHOWING ELEVATED LIVER ENZYMES ARE REPORTED BUT NOT INCLUDED. THERAPY WAS CONTINUED FOR APPROXIMATELY 1.5 MONTHS PRIOR TO CESSATION. NO LABORATORY DATA HAS BEEN PROVIDED AND THE REPORTED DATE OF THE INCIDENT IS (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144665 QUANTIFERON QUANTIFERON TB GOLD NCD CELLESTIS LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1