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.
[3394833]
The pt's lawyer alleges that (b)(6) was tested and found to be (b)(6) 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 pt was being screened for latent (b)(6) prior to being prescribed for humira. "as a result of the positive test, (b)(6) was begun on a nine (9) month therapy program with (b)(6), which caused a severe negative reaction in (b)(6) body. Shortly after being administered the (b)(6) therapy, (b)(6) began feeling terrible with body aches, headaches, lethargy, etc. As time went on, she began feeling worse and worse. It was later learned that the (b)(6) therapy caused her liver enzymes to go sky high, it caused her underlying thyroid condition (which has been fully stable for 15 years) to become unstable causing hypo-thyroidism, it caused her blood pressure to rise for which she had to seek treatment from a cardiologist and caused her to have to go on blood pressure medication, which she had previously never needed in her life, and caused various other health issues in (b)(6). "
Patient Sequence No: 1, Text Type: D, B5
[10623896]
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 (recall reference # 3003964343-01/28/13-001-r), nor is it evident that the positive result was false. If the recalled lot of tb 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 problem reported are the outcomes of subsequent treatment of the pt using isoniazid.
Patient Sequence No: 1, Text Type: N, H10
[35328156]
During an fda inspection (march 17-25, 2015) of cellestis limited, an omission of the "date received by manufacturer" was identified as a deficiency. This update is to provide the date.
Patient Sequence No: 1, Text Type: N, H10
[35328157]
The patient's lawyer alleges that (b)(6) was tested and found to be positive for (b)(6) based on the use of a cellestis quantiferon (b)(4) gold test. The assumption is the test was performed on a lot of (b)(4) tubes which was recalled by the firm (reference 3003964343-01/2813-001-r). The patient was being screened for (b)(6) prior to being prescribed for (b)(6). "as a result of the positive test, (b)(6) was begun on a nine (9) month therapy program with isoniazid, which caused a severe negative reaction in (b)(6)'s body. Shortly after being administered the isoniazid therapy, (b)(6) began feeling terrible with body aches, headaches, lethargy, etc. As time went on, she began feeling worse and worse. It was later learned that the isoniazid therapy caused her liver enzymes to go sky high, it caused her underlying thyroid condition (which has been fully stable for 15 years) to become unstable causing hypo-thyroidism, it caused her blood pressure to rise for which she had to seek treatment from a cardiologist and caused her to have to go to blood pressure medication, which she had previously never needed in her life, and caused various other health issues in (b)(6). "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003964343-2013-00001 |
| MDR Report Key | 3057647 |
| Report Source | 00,OTHER |
| Date Received | 2013-04-09 |
| Date of Report | 2013-04-08 |
| Date of Event | 2012-08-02 |
| Date Mfgr Received | 2013-01-23 |
| Device Manufacturer Date | 2011-11-01 |
| 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 |