FDA.reportPublic FDA data

MAUDE MDR 7822920

MDR report key
7822920
Report number
1950204-2018-00301
Event key
0
Event type
3
Date received
2018-08-28
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. 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 ID TEST KITVITEK? 2 GN ID TEST KITBIOMERIEUX INC.LQM213412410438103R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-280

Event Narratives#

D

Patient 1

A CUSTOMER IN THE UNITED STATES NOTIFIED BIOM?RIEUX OF MISIDENTIFICATION RESULTS FOR AN ESCHERICHIA COLI ISOLATED FROM A PATIENT URINE SAMPLE WHEN TESTING WITH VITEK? 2 GN ID TEST KIT. VITEK 2 PROVIDED AN IDENTIFICATION OF SALMONELLA SER. TYPHI. THE CUSTOMER SENT THE ISOLATE TO THE STATE REFERENCE LAB, AND THEY OBTAINED AN IDENTIFICATION OF ESCHERICHIA COLI. THE CUSTOMER NO LONGER HAS THE ISOLATE TO SUBMIT FOR EVALUATION. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOM?RIEUX INTERNAL INVESTIGATION WILL BE INITIATED.