QUANTIFERON TB GOLD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-05-01 for QUANTIFERON TB GOLD manufactured by Cellestis Limited.

Event Text Entries

[17214375] The pt (b)(6) claims that he was tested and found to be (b)(6) for (b)(6) based on the use of a cellestis quantiferon tb gold test. The assumption is the test was performed on a lot of (b)(6)tubes which were recalled by the firm (ref 3003964343-01/28/13-001-r). The pt was put on treatment with (b)(6). After receiving notification of the recall, the pt was retested on (b)(6) 2012 which was found to be (b)(6) for (b)(6). The pt claims that he suffered emotionally from this incident.
Patient Sequence No: 1, Text Type: D, B5


[17507634] As a result of a capa investigation, past legal communication was found that was identified as requiring a medwatch report. 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. Based upon the intended use of the product, if a positive result is obtained, the physician is advised to repeat the test for confirmation, and in general the results of the screening test are to be taken into consideration with the patient's epidemiological history, current medical status and results of other diagnostic evaluations. The alleged problems reported are the outcome of diagnosis, and subsequent treatment of the pt using (b)(6). Cellestis filed notification of their voluntary recall through the regional fda district recall office on 10/16/2012. Closure of the recall by the fda was received 4/25/2013.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3003964343-2015-00001
MDR Report Key4747518
Report Source04
Date Received2015-05-01
Date of Report2015-04-30
Date of Event2012-06-12
Date Mfgr Received2013-07-04
Date Added to Maude2015-06-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactDONNA SOWERS
Manufacturer Street19300 GERMANTOWN RD
Manufacturer CityGERMANTOWN MD 20874
Manufacturer CountryUS
Manufacturer Postal20874
Manufacturer Phone2406867876
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number3003964343-01/28/13-001-
Event Type3
Type of Report3

Device Details

Brand NameQUANTIFERON TB GOLD
Generic NameNONE
Product CodeNCD
Date Received2015-05-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCELLESTIS LIMITED
Manufacturer AddressCHADSTONE, VICTORIA AS


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-05-01

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