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.
[20352764]
The pt ((b)(6)) alleges that to have been tested and found to be (b)(6) based on the use of (b)(6). The assumption is the test was performed on a lot of (b)(6) tubes which was recalled by the firm (reference 3003964343-01/28/001-r). The pt was being screened for latent (b)(6) as a health care student and requirement of the institution where clinical activities are part of the curriculum. As a consequence of the diagnosis of (b)(6) the pt was prescribed therapy (b)(6). "the pills made me feel weak at all times, fatigued more than my normal student activities would cause, having difficulties concentrating, feeling faint, slightly nauseated throughout the day and the worse (sic) of them all was the itching i experienced overnight" resulting in loss of sleep. Test results showing elevated liver enzymes are reported but not included. Therapy was continued for approximately 1. 5 months prior to cessation. 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
[20424745]
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 (b)(6) using material from cellestis which was recalled by the firm (recall reference # 3003964343-01/28/13-001-r), (b)(6). If the recalled lot of (b)(6) tubes was indeed used, and a false positive 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 reported are the outcomes of subsequent treatment of the pt using (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[34533440]
This update is to provide the date.
Patient Sequence No: 1, Text Type: N, H10
[34533441]
The patient (ds) alleges that to have been 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)). The patient was being screened for latent (b)(6) as a health care student and requirement of the institution where clinical activities are part of the curriculum. As a consequence of the diagnosis of (b)(6) the patient was prescribed therapy of rifampin - 600 mg - for four months. "the pills made me feel weak at all times, fatigued more than my normal student activities would cause having difficulties concentrating, feeling faint, slightly nauseated throughout the day and the worse (sic) of them all was the itching i experienced overnight" resulting in loss of sleep. Test results showing elevated liver enzymes are reported but not included. Therapy was continued for approximately 1. 5 months prior to cessation. 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 | 3003964343-2013-00003 |
| MDR Report Key | 3057623 |
| Report Source | 04,CONSUMER |
| Date Received | 2013-04-09 |
| Date of Report | 2013-04-08 |
| Date of Event | 2012-08-01 |
| Date Mfgr Received | 2012-10-29 |
| Date Added to Maude | 2013-06-07 |
| 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 | 300396434-01/28/13-001R |
| 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 |