BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTIFERON

    MDR report key: 3057647 · Received April 9, 2013

    Report

    Report Number
    3003964343-2013-00001
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    August 2, 2012
    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
    FL, 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 (RECALL REFERENCE # 3003964343-01/28/13-001-R), NOR IS IT EVIDENT THAT THE POSITIVE RESULT WAS FALSE. IF THE RECALLED LOT OF TB 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 PROBLEM REPORTED ARE THE OUTCOMES OF SUBSEQUENT TREATMENT OF THE PT USING ISONIAZID.

    Additional Manufacturer Narrative · 1

    DURING AN FDA INSPECTION (MARCH 17-25, 2015) OF CELLESTIS LIMITED, AN OMISSION OF THE "DATE RECEIVED BY MANUFACTURER" WAS IDENTIFIED AS A DEFICIENCY. 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) BASED ON THE USE OF A CELLESTIS QUANTIFERON TB GOLD TEST. THE ASSUMPTION IS THE TEST WAS PERFORMED ON A LOT OF TB TUBES WHICH WAS RECALLED BY THE FIRM (REFERENCE 3003964343-01/28/13-001-R). THE PT WAS BEING SCREENED FOR LATENT (B)(6) PRIOR TO BEING PRESCRIBED FOR HUMIRA. "AS A RESULT OF THE POSITIVE TEST, (B)(6) WAS BEGUN ON A NINE (9) MONTH THERAPY PROGRAM WITH (B)(6), WHICH CAUSED A SEVERE NEGATIVE REACTION IN (B)(6) BODY. SHORTLY AFTER BEING ADMINISTERED THE (B)(6) THERAPY, (B)(6) BEGAN FEELING TERRIBLE WITH BODY ACHES, HEADACHES, LETHARGY, ETC. AS TIME WENT ON, SHE BEGAN FEELING WORSE AND WORSE. IT WAS LATER LEARNED THAT THE (B)(6) THERAPY CAUSED HER LIVER ENZYMES TO GO SKY HIGH, IT CAUSED HER UNDERLYING THYROID CONDITION (WHICH HAS BEEN FULLY STABLE FOR 15 YEARS) TO BECOME UNSTABLE CAUSING HYPO-THYROIDISM, IT CAUSED HER BLOOD PRESSURE TO RISE FOR WHICH SHE HAD TO SEEK TREATMENT FROM A CARDIOLOGIST AND CAUSED HER TO HAVE TO GO ON BLOOD PRESSURE MEDICATION, WHICH SHE HAD PREVIOUSLY NEVER NEEDED IN HER LIFE, AND CAUSED VARIOUS OTHER HEALTH ISSUES IN (B)(6)."

    Description of Event or Problem · 1

    THE PATIENT'S LAWYER ALLEGES THAT (B)(6) WAS TESTED AND FOUND TO BE POSITIVE FOR (B)(6) BASED ON THE USE OF A CELLESTIS QUANTIFERON (B)(4) GOLD TEST. THE ASSUMPTION IS THE TEST WAS PERFORMED ON A LOT OF (B)(4) TUBES WHICH WAS RECALLED BY THE FIRM (REFERENCE 3003964343-01/2813-001-R). THE PATIENT WAS BEING SCREENED FOR (B)(6) PRIOR TO BEING PRESCRIBED FOR (B)(6). "AS A RESULT OF THE POSITIVE TEST, (B)(6) WAS BEGUN ON A NINE (9) MONTH THERAPY PROGRAM WITH ISONIAZID, WHICH CAUSED A SEVERE NEGATIVE REACTION IN (B)(6)'S BODY. SHORTLY AFTER BEING ADMINISTERED THE ISONIAZID THERAPY, (B)(6) BEGAN FEELING TERRIBLE WITH BODY ACHES, HEADACHES, LETHARGY, ETC. AS TIME WENT ON, SHE BEGAN FEELING WORSE AND WORSE. IT WAS LATER LEARNED THAT THE ISONIAZID THERAPY CAUSED HER LIVER ENZYMES TO GO SKY HIGH, IT CAUSED HER UNDERLYING THYROID CONDITION (WHICH HAS BEEN FULLY STABLE FOR 15 YEARS) TO BECOME UNSTABLE CAUSING HYPO-THYROIDISM, IT CAUSED HER BLOOD PRESSURE TO RISE FOR WHICH SHE HAD TO SEEK TREATMENT FROM A CARDIOLOGIST AND CAUSED HER TO HAVE TO GO TO BLOOD PRESSURE MEDICATION, WHICH SHE HAD PREVIOUSLY NEVER NEEDED IN HER LIFE, AND CAUSED VARIOUS OTHER HEALTH ISSUES IN (B)(6)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144299 QUANTIFERON QUANTIFERON TB GOLD NCD CELLESTIS LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1