FDA.reportPublic FDA data

MAUDE MDR 7679674

MDR report key
7679674
Report number
1950204-2018-00252
Event key
0
Event type
3
Date received
2018-07-11
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. TIFFANY HALL
Address
100 RODOLPHE STREET DURHAM NC 27712 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VITEK?2 GP TEST KITVITEK?2 GP TEST KITBIOMERIEUX, INCLQL213422420617403R *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-07-110

Event Narratives#

D

Patient 1

A CUSTOMER IN THE UNITED STATES NOTIFIED BIOM?RIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK?2 GP TEST KIT (REFERENCE 21342). THE CUSTOMER REPORTED HAVING A PATIENT WITH BLOOD CULTURE ISOLATE THAT IDENTIFIED TWICE AS PEDIOCOCCUS. THE ISOLATE WAS SENT OUT TO A REFERENCE LABORATORY AND THE IDENTIFICATION FOR THE ISOLATE IS STREPTOCOCCUS SANGUINIS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOM?RIEUX INVESTIGATION WILL BE INITIATED.