FDA.reportPublic FDA data

MAUDE MDR 7882151

MDR report key
7882151
Report number
3002769706-2018-00184
Event key
0
Event type
3
Date received
2018-09-17
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. 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
1CHROMID? VRE ID AGAR 20 PLTCHROMID? VRE ID AGAR 20 PLTBIOMERIEUX S.A.JSO430041006583800R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-09-170

Event Narratives#

D

Patient 1

A CUSTOMER IN (B)(6) REPORTED FALSE POSITIVE RESULTS WHEN USING CHROMID? VRE ID AGAR 20 PLT (LOT 1006583800). THE CUSTOMER PERFORMED TESTS WITH RECTAL SAMPLES FROM THREE (3) PATIENTS, AND GROWTH OF TYPICAL PURPLE COLONIES OF ENTEROCOCCUS FAECIUM VANCOMYCIN B WERE OBTAINED. THE IDENTIFICATION OF THE STRAINS WAS CONFIRMED AS ENTEROCOCCUS FAECIUM WITH MASS SPECTROMETRY. THE CUSTOMER STATED THAT QC RESULTS WERE CONFORMING. THE CUSTOMER TESTED THE STRAINS ON THE VITEK? 2 AST-P606 CARD AND THE RESULTS WERE VANCOMYCIN SUSCEPTIBLE THE CUSTOMER SENT THE STRAINS TO ANOTHER LABORATORY (CNR) AND THE RESULTS WERE NEGATIVE WITH PCR AND MICRODILUTION. THE CUSTOMER STATED THAT THE RESULTS WERE REPORTED TO THE CLINICIAN AND THE PATIENTS WERE ISOLATED UNNECESSARILY. THE PATIENTS DID NOT HAVE ANTIBIOTIC TREATMENT. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOM?RIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO PATIENT'S STATE OF HEALTH. A BIOM?RIEUX INTERNAL INVESTIGATION WILL BE INITIATED.