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.
[5885711]
The pt (es) claims that she was tested and found to be positive for (b)(6) based on the use of a cellestis quantiferon (b)(6) gold test. The assumption is the test was performed on a lot of (b)(6) tubes which were recalled by the firm ((b)(4)). The pt underwent treatment with isoniazid. The pt could not take her psoriasis medication while she was being treated. After receiving notification of the recall, the pt claims that since she couldn't take her medication she suffered a lot of pain from her psoriasis which covered 75% of her body.
Patient Sequence No: 1, Text Type: D, B5
[13328943]
As a result of a capa investigation, past legal communication was found that was identified as requiring a medwatch report. 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 | 3003964343-2015-00005 |
| MDR Report Key | 4747485 |
| Report Source | 04 |
| Date Received | 2015-05-01 |
| Date of Report | 2015-04-30 |
| Date Added to Maude | 2015-06-11 |
| 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 Age | DA |
| 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 |