MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-12 for QUANTIFERON TB GOLD manufactured by Cellestis Ltd.
[24149854]
Legal communication was rec'd that was identified as requiring a medwatch report. The company has decided to submit this mdr for info purposes in an abundance of caution and to ensure ful compliance w/21 cfr part 803. Based upon the intended use of the product, if a positive result is obtained, the physician is advised to repeat the test for confirmation, and in general the results of the screening test are to be taken into consideration w/the patient's epidemiological history, current medical status and results of other diagnostic evaluations. The patient had been given a chest x-ray prior to beginning treatment w/humira on (b)(6) 2012 & the result for acute (b)(6). The alleged problems reported are the outcome of diagnosis, and subsequent treatment. Cellestis does not comment on the allegations made by the patient. We have elected to report this event to the fda for info only & the info within this report is not admission of fault in the product. Cellestis filed notification of the voluntary recall through the regional fda district recall office on 160 oct 2012. Closure of the recall by the fda was rec'd 25 apr 2013.
Patient Sequence No: 1, Text Type: N, H10
[24149855]
The patient's atty claims that his patient (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 were recalled by the firm (reference 3003964343-01/28/13-001-r). At the time of tb diagnoses, the patient was undergoing treatment for crohn's disease. The patient was informed by her doctor that she had to delay her immunosuppressive therapy and begin treatment w/inh & pyridoxine due to the positive quantiferon tb gold test. The patient underwent treatment for 4 1/2 months. After receiving notification of the recall, the patient was re-tested on (b)(6 )2012 & found to be (b)(6). The patient claim she suffered significant physical damages and emotional distress as a result of the (b)(6) diagnosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003964343-2015-00006 |
| MDR Report Key | 5001352 |
| Date Received | 2015-08-12 |
| Date of Report | 2015-08-11 |
| Date of Event | 2012-08-08 |
| Date Mfgr Received | 2015-08-06 |
| Date Added to Maude | 2015-08-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DONNA SOWERS |
| Manufacturer Street | 19300 GERMANTOWN RD. |
| Manufacturer City | GERMANTOWN MD 20874 |
| Manufacturer Country | US |
| Manufacturer Postal | 20874 |
| Manufacturer Phone | 2406867876 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 3003964343-01/28/13-001- |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | QUANTIFERON TB GOLD |
| Generic Name | NON |
| Product Code | NCD |
| Date Received | 2015-08-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CELLESTIS LTD |
| Manufacturer Address | CHADSTONE, VICTORIA AS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-12 |