MAUDE Adverse Event Report: CELLESTIS LIMITED QUANTIFERON TB GOLD; NONE

Device Problems False Positive Result (1227); Nonstandard Device (1420)

Patient Problem Emotional Changes (1831)

Event Date 06/12/2012

Event Type  malfunction  

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: QUANTIFERON TB GOLD
• Type of Device: NONE
• Manufacturer (Section D): CELLESTIS LIMITED; chadstone, victoria ; AS
• Manufacturer Contact: donna sowers ; 19300 germantown rd; germantown, MD 20874 ; 2406867876
• MDR Report Key: 4747518
• MDR Text Key: 17214375
• Report Number: 3003964343-2015-00001
• Device Sequence Number: 1
• Product Code: NCD
• Combination Product (y/n): N
• PMA/PMN Number: P010033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/04/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3003964343-01/28/13-001-
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR