QUANTIFERON-TB GOLD TEST

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-11 for QUANTIFERON-TB GOLD TEST manufactured by Qiagen (cellestis).

Event Text Entries

[4083758] Over the past two months, a number of physician have rate of both indeterminate and positive results with the quantiferon-tb gold (qft) test manufactured by (b)(4), and we suspect that in some cases pts or employee staff may have received add'l testing or clinical interventions based on this info, up to and including chest x-rays and treatment with inh. Working in conjunction with an in network lab, which performs the assay for us, we have been monitoring the situation and conferring with the mfr to ascertain the nature and extent of the problem. Recently (b)(4) acknowledge that there were issues with components of the "mitogen" tube, which resulted in a several-fold increase in the rate of indeterminate results. Last week, we learned that they have also encountered problems with the "tb" tube, the nature of which they do not yet fully understand, but which has been associated with positive rates of up to (b)(4) at some of our sites. Prior baseline positive rates were in the range of (b)(4). Given that they neither fully understand the cause of this increase in positive test results or are able to unequivocally provide assurance that new tubes will correct the situation, we feel it is both prudent and ethical to report this issue to the fda. We temporarily suspended use of the quantiferon testing on (b)(6) and will resume use once (b)(4) provides us with replacement lots. Since we earlier were supplied with replacement lots that did not alleviate the problem, we will re-test any positive and indeterminate results with the quantiferon and t-spot test at a great expense to ourselves. (b)(6) testing.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5032731
• MDR Report Key: 3469619
• Date Received: 2013-11-11
• Date of Report: 2013-11-08
• Date Added to Maude: 2013-11-15
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: QUANTIFERON-TB GOLD TEST
• Generic Name: TUBERCULOSIS TEST
• Product Code: NCD
• Date Received: 2013-11-11
• Lot Number: A1301
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: QIAGEN (CELLESTIS)

Device Sequence Number: 2

• Brand Name: QUANTIFERON-TB GOLD TEST
• Generic Name: TUBERCULOSIS TEST
• Product Code: NCD
• Date Received: 2013-11-11
• Lot Number: A1302
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: QIAGEN (CELLESTIS)

Device Sequence Number: 3

• Brand Name: QUANTIFERON-TB GOLD TEST
• Generic Name: TUBERCULOSIS TEST
• Product Code: NCD
• Date Received: 2013-11-11
• Lot Number: A1303
• Device Availability: Y
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: QIAGEN (CELLESTIS)

Device Sequence Number: 4

• Brand Name: QUANTIFERON-TB GOLD TEST
• Generic Name: TUBERCULOSIS TEST
• Product Code: NCD
• Date Received: 2013-11-11
• Lot Number: A1304
• Device Availability: Y
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: QIAGEN (CELLESTIS)

Device Sequence Number: 5

• Brand Name: QUANTIFERON-TB GOLD TEST
• Generic Name: TUBERCULOSIS TEST
• Product Code: NCD
• Date Received: 2013-11-11
• Lot Number: A1305
• Device Availability: Y
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: QIAGEN (CELLESTIS)

Device Sequence Number: 6

• Brand Name: QUANTIFERON-TB GOLD TEST
• Generic Name: TUBERCULOSIS TEST
• Product Code: NCD
• Date Received: 2013-11-11
• Lot Number: A1306
• Device Availability: Y
• Device Sequence No: 6
• Device Event Key: 0
• Manufacturer: QIAGEN (CELLESTIS)

Device Sequence Number: 7

• Brand Name: QUANTIFERON-TB GOLD TEST
• Generic Name: TUBERCULOSIS TEST
• Product Code: NCD
• Date Received: 2013-11-11
• Lot Number: A1307
• Device Availability: Y
• Device Sequence No: 7
• Device Event Key: 0
• Manufacturer: QIAGEN (CELLESTIS)

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2013-11-11