BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTIFERON

    MDR report key: 3057622 · Received April 9, 2013

    Report

    Report Number
    3003964343-2013-00005
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    August 21, 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
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 HAD 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) 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 (B)(6) 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 PROBLEM REPORTED ARE THE OUTCOMES OF SUBSEQUENT TREATMENT OF THE PT USING ISONIAZID.

    Description of Event or Problem · 1

    THE PATIENT'S LAWYER ALLEGES THAT JC WAS TESTED AND FOUND TO BE POSITIVE FOR TUBERCULOSIS (TB) 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 PATIENT WAS BEING SCREENED FOR LATENT TB PRIOR TO BEING PRESCRIBED FOR AN IMMUNOSUPPRESSANT DRUG TO TREAT ECZEMA. "BECAUSE OF THE POSITIVE TB TEST, HIS DERMATOLOGIST WAS UNABLE TO BEGIN HIM ON A IMMUNOSUPPRESSANT DRUG TO TREAT ECZEMA. AS A RESULT, JC SUFFERED SIDE EFFECTS BECAUSE OF THE ANTITUBERCULIN (SIC) DRUG." THE ATTORNEY CLAIMS THAT THE POSITIVE TB RESULT LEAD TO THE PATIENT'S LOSS OF EMPLOYMENT. 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'S LAWYER ALLEGES THAT (B)(6) WAS TESTED AND FOUND TO BE (B)(6) BASED ON THE USE OF A CELLESTIS QUANTIFERON (B)(4). THE ASSUMPTION IS THE TEST WAS PERFORMED ON A LOT OF (B)(6) 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 AN IMMUNO-SUPPRESSANT DRUG TO TREAT ECZEMA. "BECAUSE OF THE (B)(6) TEST, HIS DERMATOLOGIST WAS UNABLE TO BEGIN HIM ON AN IMMUNO-SUPPRESSANT DRUG TO TREAT ECZEMA. AS A RESULT, (B)(6) SUFFERED SIDE EFFECTS BECAUSE OF THE (B)(6) DRUG." THE ATTORNEY CLAIMS THAT THE (B)(6) RESULT LEAD TO THE PT'S LOSS OF EMPLOYMENT. 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
    144508 QUANTIFERON QUANTIFERON TB GOLD NCD CELLESTIS LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1