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.
[3394340]
The pt's lawyer alleges that (b)(6) was tested and found to be positive for tuberculosis (b)(6) based on the use of a (b)(4) test. The assumption is the test was performed on a lot of (b)(4) which was recalled by the firm ((b)(4)). The pt was being screened for (b)(6) at (b)(6) after a (b)(6). "as a result of this (b)(6), (b)(6) was prescribed (b)(6); and ultimately developed (b)(6). (b)(6) started having daily severe stomach pain and cramping which interfered with her sleep. (b)(6) liver lab values, specifically, ast and alt values were (and are still) abnormal. " medical test data from (b)(6) was included with this report.
Patient Sequence No: 1, Text Type: D, B5
[10623548]
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 ((b)(4)), nor is it evident that the (b)(6). A letter from the pt's physician indicates that prior to the cellestis test, the pt would have been treated in the same manner based on only the (b)(6) test results. If the recalled lot of (b)(4) 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 reported are the outcomes of subsequent treatment of the pt using (b)(6). Medical test data provided does show elevation of liver enzymes following treatment and their decline following cessation of therapy to normal levels for alt. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[29687222]
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
[29687226]
The patient's lawyer alleges that (b)(6) was tested and found to be (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 3003964343-01/28/13-001-r). The patient was being screened for latent (b)(4) at (b)(6) after a (b)(6). "as a result of this false positive test, (b)(6) was prescribed isoniazid; and , ultimately developed isoniazid toxicity. (b)(6) started having daily severe stomach pain and cramping which interfered with her sleep. (b)(6) liver lab values, specifically, ast and alt values were (and are still) abnormal. " medical test data from the (b)(6) was included with the original report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003964343-2013-00006 |
| MDR Report Key | 3057621 |
| Report Source | 00,OTHER |
| Date Received | 2013-04-09 |
| Date of Report | 2013-04-08 |
| Date of Event | 2013-02-08 |
| Date Mfgr Received | 2013-02-08 |
| 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 |