MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,other report with the FDA on 2013-04-09 for QUANTIFERONQ manufactured by Cellestis Limited.
[3363229]
The pt's lawyer alleges that (b)(6) was tested and found to be (b)(6) for (b)(6) based on the use of a cellestis (b)(6) test. The assumption is the test was performed on a lot of (b)(6) tubes which was recalled by the firm ((b)(4)). As a consequence of the diagnosis of (b)(6) for (b)(6) the pt was prescribed therapy of (b)(6) and this allegedly caused "fatigue, chronic headaches, cognitive difficulties, general myalgias and to some degree, swelling and numbness in her hands. " these complications allegedly resulted in the pt losing employment, and encountering marital and family difficulties. The reported date of the incident is approximately (b)(6) 2012.
Patient Sequence No: 1, Text Type: D, B5
[10623549]
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 tb infection using material from cellestis which was recalled by the firm ((b)(4)), nor is it evident that the positive 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 problems are reported to be the outcomes of complications related to the (b)(6) therapy.
Patient Sequence No: 1, Text Type: N, H10
[34532873]
This update is to provide the date.
Patient Sequence No: 1, Text Type: N, H10
[34532874]
The patient's lawyer alleges that bk 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 was recalled by the firm (reference (b)(4)). As a consequence of the diagnosis of positive for (b)(6) the patient was prescribed therapy of isoniazid and this allegedly caused "fatigue, chronic headaches, cognitive difficulties, general myalgias and to some degree, swelling and numbness in her hands. " these complications allegedly resulted in the patient losing employment, and encountering marital and family difficulties. The reported date of the incident is approximately (b)(6) 2012.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003964343-2013-00002 |
| MDR Report Key | 3057646 |
| Report Source | 00,OTHER |
| Date Received | 2013-04-09 |
| Date of Report | 2013-04-08 |
| Date of Event | 2013-02-18 |
| Date Mfgr Received | 2013-02-18 |
| Date Added to Maude | 2013-06-06 |
| 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 Street | 28358 CONSTELLATION ROAD UNIT 698 |
| Manufacturer City | VALENCIA CA 91355 |
| Manufacturer Country | US |
| Manufacturer Postal | 91355 |
| Manufacturer Phone | 6617757480 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 3003964343-01/28/13-001R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUANTIFERONQ |
| Generic Name | QUANTIFERON TB GOLD |
| Product Code | NCD |
| Date Received | 2013-04-09 |
| 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 | 2013-04-09 |