FDA.reportPublic FDA data

MAUDE MDR 5408534

MDR report key
5408534
Report number
1122376-2016-00009
Event key
0
Event type
3
Date of event
2013-04-03
Date received
2016-02-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. DONNA SOWERS
Address
28358 CONSTELLATION ROAD UNIT 698 VALENCIA CA 91355 US
Phone
240-240-2406
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CELLESTISQUANTIFERON TB GOLDCELLESTIS, INC.NCD0592-0601A1210004Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-02-030

Event Narratives#

N

Patient 1

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.

D

Patient 1

CUSTOMER COMPLAINT RECEIVED STATING HIGH RATE OF POSITIVE AND GREY-ZONE RESULTS FOR RECRUIT TB SCREENING TESTS SEEN AT 2 SITES.