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

Catalog Number	T0590-0301
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2012
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As a result of a capa investigation, historical complaints were found that were identified as requiring a medwatch report.The company has decided to submit this mdr for information purposes to ensure full compliance with 21cfr part 803.(b)(4).
Event or Problem Description
Cellestic customer (b)(4) received where customer reported that they drew 5 samples on monday ((b)(6)) before training.During the first day of training , the samples were run and all resulted as positive.They stated that they had worked in many different labs in the hospitals and with lots of patients.That same day the samples were redrawn plus an additional 2 samples.They repeated as positive on the second day of training, with the additional 2 samples as negative.The validation samples that were supplied resulted as expected with a mixture of positives and negative results.The customer sent the 7 tubes that were drawn for the second day of testing to their lab in sioux falls, and they confirmed the positive and negative results.The customer then ordered a new tube lot and redrew the same 7 samples.They ran these samples in their lab and sent them to mayo to run.All are negative.They are convinced that it is the lot of tubes.

• Brand Name: CELLESTIS
• Common Device Name: QUANTIFERON TB GOLD
• Manufacturer (Section D): CELLESTIS INC; 28358 constellation road; unit 698; valencia 91355
• MDR Report Key: 5408484
• Report Number: 1122376-2016-00002
• Device Sequence Number: 279082
• Product Code: NCD
• UDI-Device Identifier: 04053228002109
• UDI-Public: 04053228002109
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P010033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• 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: No Information
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: T0590-0301
• Device Lot Number: A111103N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2012
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3003964343-01/28/13-001R
• Patient Sequence Number: 1