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 QUANTIFERON manufactured by Cellestis Limited.
[20632679]
The pt's lawyer alleges that (b)(6) was tested and found to be (b)(6) based on the use of a cellestis quantiferon (b)(4). The assumption is the test was performed on a lot of (b)(6) tubes which was recalled by the firm (reference 3003964343-01/28/13-001-r). The pt was being screened for latent (b)(6) prior to being prescribed for an immuno-suppressant drug to treat eczema. "because of the (b)(6) test, his dermatologist was unable to begin him on an immuno-suppressant drug to treat eczema. As a result, (b)(6) suffered side effects because of the (b)(6) drug. " the attorney claims that the (b)(6) result lead to the pt's loss of employment. No laboratory data has been provided and the reported date of the incident is (b)(6) 2012.
Patient Sequence No: 1, Text Type: D, B5
[20867220]
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 had 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) infection using material from cellestis which was recalled by the firm (recall reference # 3003964343-01/28/13-001-r), nor is it evident that the (b)(6) 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 problem reported are the outcomes of subsequent treatment of the pt using isoniazid.
Patient Sequence No: 1, Text Type: N, H10
[34370214]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[34370215]
The patient's lawyer alleges that jc was tested and found to be positive for tuberculosis (tb) 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 was recalled by the firm (reference 3003964343-01/28/13-001-r) the patient was being screened for latent tb prior to being prescribed for an immunosuppressant drug to treat eczema. "because of the positive tb test, his dermatologist was unable to begin him on a immunosuppressant drug to treat eczema. As a result, jc suffered side effects because of the antituberculin (sic) drug. " the attorney claims that the positive tb result lead to the patient's loss of employment. No laboratory data has been provided and the reported date of the incident is (b)(6) 2012.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003964343-2013-00005 |
| MDR Report Key | 3057622 |
| Report Source | 00,OTHER |
| Date Received | 2013-04-09 |
| Date of Report | 2013-04-08 |
| Date of Event | 2012-08-21 |
| Date Mfgr Received | 2012-12-13 |
| 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 | QUANTIFERON |
| 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 |