FDA.reportPublic FDA data

MAUDE MDR 7799196

MDR report key
7799196
Report number
1950204-2018-00293
Event key
0
Event type
3
Date received
2018-08-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. DEBRA BROYLES
Address
595 ANGLUM ROAD HAZELWOOD 63042 US
Phone
314-314-3147
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VITEK? 2 GN TEST KITVITEK? 2 GN TEST KITBIOMERIEUX, INC.LQM213412410326203R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-200

Event Narratives#

D

Patient 1

AN INDUSTRIAL CUSTOMER IN (B)(6) REPORTED A MISIDENTIFICATION OF SALMONELLA SPP AS SERRATIA FONTICOLA WHEN TESTING A BIOSAFETY LEVEL 3 PRODUCTION STRAIN, FROM FERMENTOR CULTURE, IN ASSOCIATION WITH THE VITEK? 2 GN TEST KIT. THE CUSTOMER WAS EXPECTING TO HAVE AN IDENTIFICATION FOR SALMONELLA SPP, BUT OBTAINED AN EXCELLENT IDENTIFICATION OF SERRATIA FONTICOLA (99%). THE CUSTOMER STATED THE THREE VITEK TESTS THAT SHOULD BE POSITIVE FOR SALMONELLA SPP (DMAL, PROA AND TYRA) WERE NEGATIVE. THE CUSTOMER IDENTIFIED SALMONELLA SPP BY THE MALDI-TOF METHOD. THE CULTURE MEDIUM USED IS NOT KNOWN. THERE IS NO PATIENT INVOLVEMENT AS THE EVENT PERTAINED TO AN INDUSTRIAL PRODUCTION STRAIN. THE STRAIN IS NOT AVAILABLE FOR EVALUATION. A BIOM?RIEUX INTERNAL INVESTIGATION WILL BE INITIATED.