MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-05-01 for QUANTIFERON TB GOLD manufactured by Cellestis Limited.
[5709862]
The patient's attorney claims that the pt (b)(6) was tested and found to be positive for (b)(6) based on the use of a cellestis quantiferon (b)(6) gold test. The assumption of the test was performed on a lot of (b)(6) tubes which were recalled by the firm ((b)(4)). (b)(6) was put on aggressive treatment. (b)(6) could not take her rheumatoid arthritis (ra) medication while she was being treated. After receiving notification of the recall, (b)(6) was re-tested by 2 different laboratories and found to be negative. The patient's attorney claims that (b)(6) suffered the recurrence of serious ra symptoms and missed work.
Patient Sequence No: 1, Text Type: D, B5
[13328945]
As a result of a capa investigation, past legal communication was found that was identified as requiring a medwatch report. 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. 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 with the patient's epidemiological history, current medical status and results of other diagnostic evaluations. The alleged problems reported are the outcome of diagnosis, and subsequent treatment. Cellestis filed notification of their voluntary recall through the regional fda district recall office on 10/16/2012. Closure of the recall by the fda was received 4/25/2013
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003964343-2015-00004 |
| MDR Report Key | 4747489 |
| Report Source | 04 |
| Date Received | 2015-05-01 |
| Date of Report | 2015-04-30 |
| Date Added to Maude | 2015-06-12 |
| 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 | 0 |
| Event Location | 0 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 3003964343-01/28/13-001- |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUANTIFERON TB GOLD |
| Generic Name | NONE |
| Product Code | NCD |
| Date Received | 2015-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CELLESTIS LIMITED |
| Manufacturer Address | CHADSTONE, VICTORIA 3148 AS 3148 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-01 |