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	01/10/2014
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)(4).Due to the similarity to a us product, in an abundance of caution, qiagen is filing a report.
Event or Problem Description
Customer complaint received stating that the ratios of positive and gray zones were high in the medical checkups for 30 healthcare workers and 42 inpatients.Similar cases were seen in the same lot.

• 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: 5408497
• Report Number: 1122376-2016-00007
• Device Sequence Number: 16298769
• Product Code: NCD
• UDI-Device Identifier: 04053228002109
• UDI-Public: 04053228002109
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P010033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• 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