FDA.reportPublic FDA data

MAUDE MDR 8087036

MDR report key
8087036
Report number
3002769706-2018-00242
Event key
0
Event type
3
Date received
2018-11-19
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
1API? 20 STREPAPI? 20 STREPBIOMERIEUX, SAJTO206001006278700R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-11-190

Event Narratives#

D

Patient 1

A CUSTOMER IN (B)(6) REPORTED A MISIDENTIFICATION OF AN ENTEROCOCCUS GALLINARUM SURVEY SAMPLE (CQE ECBU 2018-3A PROSPECTIVE BIOLOGY 11.1646 ) AS ENTEROCOCCUS FAECIUM IN ASSOCIATION WITH THE API? STREP TEST STRIP. THE CUSTOMER REPEATED THE TEST SEVERAL TIMES WITH SEVERAL LOTS AND FROM DIFFERENT CULTURE MEDIA, AND OBTAINED THE SAME RESULT. THE QUALITY CONTROL WAS CONFORMING. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT PERTAINED TO A SURVEY SAMPLE. A BIOM?RIEUX INTERNAL INVESTIGATION WILL BE INITIATED.