MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,consumer report with the FDA on 2013-04-09 for QUANTIFERON manufactured by Cellestis Limited.
[17322533]
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 ((b)(4)), nor is it evident that the (b)(6) result was (b)(6). 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 (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[17348771]
The pt ((b)(6)) alleges to have been tested and found to be (b)(6) 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 ((b)(4)). The pt was being routinely screened for (b)(6) because she suffers chronic rheumatoid arthritis and is presumed to be prescribed in immunosuppressant. As a consequence of the diagnosis of (b)(6) for (b)(6), the pt was prescribed therapy of (b)(6) for five months and because the ra therapy was ceased during the period of this treatment, the pt suffered chronic pain. "i had to endure the pain of the arthritis for the duration of the time i was on (b)(6). This was extremely difficult for me to take care of two small children and work while dealing with chronic debilitating pain. " no laboratory data has been provided and the reported date of the incident is not stated.
Patient Sequence No: 1, Text Type: D, B5
[35373410]
.
Patient Sequence No: 1, Text Type: N, H10
[35373411]
The patient (b)(6) alleges to have been tested and found to be positive for (b)(6) based on the use of a (b)(6) 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 ((b)(4)). The patient was being routinely screened for latent tb because she suffers chronic rheumatoid arthritis and is presumed to be prescribed an immunosuppressant. As a consequence of the diagnosis of positive for (b)(6) the patient was prescribed therapy if (b)(6) for five months and because the ra therapy was ceased during the period of this treatment, the patient suffered chronic pain. "i had to ensure the pain of the arthritis for the duration of the time i was on izonaid (sic). This was extremely difficult for me to take care of two small children and work while dealing with chronic debilitating pain. " no laboratory data has been provided and the reported date of the incident is not stated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003964343-2013-00004 |
| MDR Report Key | 3057585 |
| Report Source | 04,CONSUMER |
| Date Received | 2013-04-09 |
| Date of Report | 2013-04-08 |
| Date Mfgr Received | 2013-04-08 |
| 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 |