FDA.reportPublic FDA data

MAUDE MDR 7837125

MDR report key
7837125
Report number
1950204-2018-00317
Event key
0
Event type
3
Date received
2018-08-31
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
1VITEK? 2 GP TEST KITVITEK? 2 GP TEST KITBIOMERIEUX, INC.LQL213422420749203R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-310

Event Narratives#

D

Patient 1

A CUSTOMER IN THE UNITED STATES REPORTED MISIDENTIFICATIONS OF STREPTOCOCCUS SPECIES FOR FOUR (4) PATIENT ISOLATES IN ASSOCIATION WITH THE VITEK? 2 GP TEST KIT (LOT 2420749203). THE CUSTOMER REPORTED THAT ALL FOUR ISOLATES WERE FROM SMALL BOWEL BRUSHINGS AND THE CULTURES WERE PURE ALPHA HEMOLYTIC ISOLATES. ISOLATE (B)(4): VITEK 2 GP: STREPTOCOCCUS PSEUDOPORCINUS (95%); REPEAT: UNIDENTIFIED ORGANISM REFERENCE LAB MALDI TOF: STREPTOCOCCUS MITIS/ORALIS ISOLATE (B)(4): VITEK 2 GP: LOW DISCRIMINATION STREPTOCOCCUS MITIS/ORALIS; REPEAT 1: LOW DISCRIMINATION STREPTOCOCCUS PSEUDOPORCINUS; REPEAT 2: LOW DISCRIMINATION GRANULICATELLA ADIACENS REFERENCE LAB MALDI TOF: STREPTOCOCCUS MITIS/ORALIS ISOLATE (B)(4): VITEK 2 GP: STREPTOCOCCUS THORALTENSIS; REPEAT: STREPTOCOCCUS MITIS/ORALIS ISOLATE (B)(4): VITEK 2 GP: STREPTOCOCCUS PSEUDOPORCINUS; REPEAT: STREPTOCOCCUS MITIS/ORALIS NO PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. 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 THE PATIENT'S STATE OF HEALTH. A BIOM?RIEUX INTERNAL INVESTIGATION WILL BE INITIATED.