FDA.reportPublic FDA data

MAUDE MDR 7052832

MDR report key
7052832
Report number
1950204-2017-00417
Event key
0
Event type
3
Date received
2017-11-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. ELLEN WELTMER
Address
595 ANGLUM ROAD HAZELWOOD MO 63042 US
Phone
314-314-3147
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VITEK? 2 ANC TEST KITVITEK? 2 ANC TEST KITBIOMERIEUX INC.JSP21347N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-11-220

Event Narratives#

D

Patient 1

A CUSTOMER IN THE UNITED STATES NOTIFIED BIOM?RIEUX OF MISIDENTIFICATION RESULTS IN ASSOCIATION WITH VITEK? 2 ANC TEST KIT (REF 21347). THE CUSTOMER REPORTED THAT THREE PATIENT STRAINS WERE TESTED WITH VITEK? 2, WHICH PROVIDED IDENTIFICATIONS OF FUSOBACTERIUM NUCLEATUM. VITEK? MS WAS USED TO TEST THE ISOLATES, AND IT PROVIDED EITHER A "NO ID" RESULT OR CAMPYLOBACTER JEJUNI RESULT. THE STATE LAB IDENTIFIED THE STRAINS AS CAMPYLOBACTER CONCISUS USING THE BRUKER METHOD. FUSOBACTERIUM NUCLEATUM WAS INCORRECTLY REPORTED TO THE PHYSICIAN FOR ONE OF THE PATIENTS. THERE IS NO INFORMATION ON REPORTED RESULTS FOR THE OTHER TWO PATIENTS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOM?RIEUX INTERNAL INVESTIGATION WILL BE INITIATED.