BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTIFERON

    MDR report key: 3057621 · Received April 9, 2013

    Report

    Report Number
    3003964343-2013-00006
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    February 8, 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
    NC, 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 (B)(6) USING MATERIAL FROM CELLESTIS WHICH WAS RECALLED BY THE FIRM ((B)(4)), NOR IS IT EVIDENT THAT THE (B)(6). A LETTER FROM THE PT'S PHYSICIAN INDICATES THAT PRIOR TO THE CELLESTIS TEST, THE PT WOULD HAVE BEEN TREATED IN THE SAME MANNER BASED ON ONLY THE (B)(6) TEST RESULTS. IF THE RECALLED LOT OF (B)(4) 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 REPORTED ARE THE OUTCOMES OF SUBSEQUENT TREATMENT OF THE PT USING (B)(6). MEDICAL TEST DATA PROVIDED DOES SHOW ELEVATION OF LIVER ENZYMES FOLLOWING TREATMENT AND THEIR DECLINE FOLLOWING CESSATION OF THERAPY TO NORMAL LEVELS FOR ALT. (B)(6).

    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 POSITIVE FOR TUBERCULOSIS (B)(6) BASED ON THE USE OF A (B)(4) TEST. THE ASSUMPTION IS THE TEST WAS PERFORMED ON A LOT OF (B)(4) WHICH WAS RECALLED BY THE FIRM ((B)(4)). THE PT WAS BEING SCREENED FOR (B)(6) AT (B)(6) AFTER A (B)(6). "AS A RESULT OF THIS (B)(6), (B)(6) WAS PRESCRIBED (B)(6); AND ULTIMATELY DEVELOPED (B)(6). (B)(6) STARTED HAVING DAILY SEVERE STOMACH PAIN AND CRAMPING WHICH INTERFERED WITH HER SLEEP. (B)(6) LIVER LAB VALUES, SPECIFICALLY, AST AND ALT VALUES WERE (AND ARE STILL) ABNORMAL." MEDICAL TEST DATA FROM (B)(6) WAS INCLUDED WITH THIS REPORT.

    Description of Event or Problem · 1

    THE PATIENT'S LAWYER ALLEGES THAT (B)(6) WAS TESTED AND FOUND TO BE (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 3003964343-01/28/13-001-R). THE PATIENT WAS BEING SCREENED FOR LATENT (B)(4) AT (B)(6) AFTER A (B)(6). "AS A RESULT OF THIS FALSE POSITIVE TEST, (B)(6) WAS PRESCRIBED ISONIAZID; AND , ULTIMATELY DEVELOPED ISONIAZID TOXICITY. (B)(6) STARTED HAVING DAILY SEVERE STOMACH PAIN AND CRAMPING WHICH INTERFERED WITH HER SLEEP. (B)(6) LIVER LAB VALUES, SPECIFICALLY, AST AND ALT VALUES WERE (AND ARE STILL) ABNORMAL." MEDICAL TEST DATA FROM THE (B)(6) WAS INCLUDED WITH THE ORIGINAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147917 QUANTIFERON QUANTIFERON TB GOLD NCD CELLESTIS LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR