CELLESTIS T0592-0201

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-02-03 for CELLESTIS T0592-0201 manufactured by Cellestis Inc..

Event Text Entries

[37439875] 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. Cellestis filed notification of their voluntary recall through the regional fda district recall office on 16oct2012. Closure of the recall by the fda was received 25apr2013.
Patient Sequence No: 1, Text Type: N, H10


[37439876] Cellestis customer complaint #(b)(4) was received that states throughout the month of (b)(6) 2012 the customer was seeing a dramatic increase in positive results, where the previous qft test was negative with no risk factors. Previous months did not show a significant increase as did (b)(6). Product associated with this complaint was found to be malfunctioning and subsequently recalled (recall reference #(b)(4)).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1122376-2016-00001
MDR Report Key5408477
Report SourceUSER FACILITY
Date Received2016-02-03
Date of Report2016-02-02
Date of Event2012-05-30
Date Mfgr Received2012-05-30
Device Manufacturer Date2011-11-01
Date Added to Maude2016-02-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. DONNA SOWERS
Manufacturer Street28358 CONSTELLATION ROAD
Manufacturer CityVALENCIA CA 91355
Manufacturer CountryUS
Manufacturer Postal91355
Manufacturer Phone2406867876
Manufacturer G1QIAGEN LLC
Manufacturer Street19300 GERMANTOWN ROAD
Manufacturer CityGERMANTOWN MD 20874
Manufacturer CountryUS
Manufacturer Postal Code20874
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number3003964343-01/28/13-001R
Event Type3
Type of Report3

Device Details

Brand NameCELLESTIS
Generic NameQUANTIFERON TB GOLD
Product CodeNCD
Date Received2016-02-03
Catalog NumberT0592-0201
Lot NumberA111103N
Device Expiration Date2013-02-28
OperatorMEDICAL TECHNOLOGIST
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCELLESTIS INC.
Manufacturer Address28358 CONSTELLATION ROAD UNIT 698 VALENCIA CA 91355 US 91355


Patients

Patient NumberTreatmentOutcomeDate
10 2016-02-03

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