MAUDE Adverse Event Report: CELLESTIS, INC. CELLESTIS; QUANTIFERON TB GOLD

Catalog Number	0592-0601
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of a capa investigation, it was determined that complaint number (b)(4) is related to a foreign recall of a product only available in (b)94).Due to the similarity to a u.S product, in an abundance of caution, qiagen is filing a report.
Event or Problem Description
Customer complaint received stating high rate of positive and grey-zone results for recruit tb screening tests seen at 2 sites.

• Brand Name: CELLESTIS
• Common Device Name: QUANTIFERON TB GOLD
• Manufacturer (Section D): CELLESTIS, INC.; 28358 constellation road; unit 698; valencia CA 91355
• MDR Report Key: 5408534
• Report Number: 1122376-2016-00009
• Device Sequence Number: 471597
• Product Code: NCD
• UDI-Device Identifier: 04053228002109
• UDI-Public: 04053228002109
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P01003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Report Date (Section B): 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Medical Technologist
• Device Expiration Date: 01/01/2014
• Device Catalogue Number: 0592-0601
• Device Lot Number: A1210004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1