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

Catalog Number T0590-0301

Device Problems Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2012

Event Type  malfunction  

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 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
• Type of Device: QUANTIFERON TB GOLD
• Manufacturer (Section D): CELLESTIS INC; 28358 constellation road; unit 698; valencia 91355
• Manufacturer (Section G): CELLESTIS INC; 28358 constellation road; valencia MD 01355
• Manufacturer Contact: donna sowers ; 19300 germantown road; germantown, MD 20874 ; 2406867876
• MDR Report Key: 5408484
• MDR Text Key: 38236281
• Report Number: 1122376-2016-00002
• Device Sequence Number: 1
• Product Code: NCD
• UDI-Device Identifier: 04053228002109
• UDI-Public: 04053228002109
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: T0590-0301
• Device Lot Number: A111103N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3003964343-01/28/13-001R
• Patient Sequence Number: 1