FDA.reportPublic FDA data

MAUDE MDR 7875079

MDR report key
7875079
Report number
1950204-2018-00361
Event key
0
Event type
3
Date received
2018-09-13
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
MS. CANDACE MARTIN
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 GRAM NEGATIVE IDENTIFICATION TEST KITVITEK? 2 GN ID TEST KITBIOMERIEUX INC.LQM213412410481403R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-09-130

Event Narratives#

D

Patient 1

A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOM?RIEUX OF MISIDENTIFICATION RESULTS FOR CAP SURVEY SPECIMEN D09 WHEN TESTING WITH THE VITEK? 2 GN ID CARD (REF 21341). THE EXPECTED ID WAS ACINETOBACTER LWOFFII, AND THE GN CARD IDENTIFIED THE SAMPLE AS ACINETOBACTER BAUMANNII TWICE. INITIAL TESTING WAS PERFORMED WITH THE LOT 2410481403. REPEAT TESTING WAS PERFORMED WITH A DIFFERENT LOT, # 2410595203. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AN INTERNAL BIOM?RIEUX INVESTIGATION HAS BEEN INITIATED.