MAUDE MDR 8025947

MDR report key
8025947
Report number
1950204-2018-00454
Event key
0
Event type
3
Date received
2018-10-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Contact
MS. DEBRA BROYLES
Address
595 ANGLUM ROAD HAZELWOOD MO 63042 US
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.LQM213412410478203R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-10-310

Event Narratives#

N

Patient 1

AN INVESTIGATION WAS PERFORMED. THE INTERNAL BIOMERIEUX CAP D-09 (2018) SURVEY STRAIN WAS SUBCULTURED TO TSAB AND MACCONKEY AGAR AND INCUBATED TO 35-37?C FOR 20-22 HOURS. A SECOND SUBCULTURE WAS PERFORMED AND TESTING INCLUDED INDIVIDUAL ORGANISM SUSPENSIONS WITH GN CARDS FROM FOUR DIFFERENT GN CARD LOTS IN DUPLICATE AS WELL AS VITEK MS. (B)(4) (BIOMERIEUX INTERNAL CAP D-09 STRAIN): THE STRAIN GREW ON MAC AGAR AS A NON-LACTOSE FERMENTING ISOLATE. ALL EIGHT GN CARDS TESTED RESULTED IN LOW DISCRIMINATION IDENTIFICATIONS OF ACINETOBACTER LWOFFII/MORAXELLA GROUP. VITEK MS RESULTED IN AN IDENTIFICATION OF ACINETOBACTER LWOFFII WITH A 99.9% CONFIDENCE VALUE. AS A. LWOFFII WAS PART OF THE LOW DISCRIMINATION CALL ON ALL GN CARDS TESTED, VITEK 2 CARDS ARE PERFORMING AS EXPECTED. NO FURTHER ACTION IS REQUIRED.

D

Patient 1

A CUSTOMER IN (B)(6) REPORTED A MISIDENTIFICATION OF AN ACINETOBACTER LWOFFII CAP SURVEY STRAIN (D-09) AS MORAXELLA GROUP WITH THE VITEK? 2 GN TEST KIT (2410478203). THE CUSTOMER REPORTED A RESULT OF MORAXELLA GROUP AND FOUND OUT LATER THAT THE EXPECTED RESULT WAS ACINETOBACTER LWOFFI, ACINETOBACTER JUNII (LWOFFI/JOHNSONII), OR ACINETOBACTER SP. THE BIOM?RIEUX LOCAL FIELD APPLICATION SPECIALIST TESTED THE ISOLATE ON THE VITEK SYSTEMS OF THE REPORTING CUSTOMER AND ANOTHER CUSTOMER, AND THE RESULT WAS MORAXELLA GROUP. THE ISOLATE WAS IDENTIFIED AS ACINETOBACTER LWOFFII WITH VITEK MS.