FDA.reportPublic FDA data

MAUDE MDR 7878611

MDR report key
7878611
Report number
1950204-2018-00364
Event key
0
Event type
3
Date received
2018-09-14
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. CANDACE MARTIN
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 AST-YS08 TEST KITVITEK? 2 AST-YS08 TEST KITBIOMERIEUX, INC.NGZ4207392880297203R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-09-140

Event Narratives#

D

Patient 1

A CUSTOMER IN (B)(6) NOTIFIED BIOM?RIEUX OF FALSE SUSCEPTIBLE FLUCONAZOLE RESULTS FOR EEQ BIOLOGIE PROSPECTIVE 2018-2A, CANDIDA GLABRATA, WHEN TESTING WITH THE VITEK? 2 AST-YS08 TEST KIT. THE CUSTOMER OBTAINED A SUSCEPTIBLE RESULT, MIC=2. THE EXPECTED RESULT FOR THIS SURVEY STRAIN IS RESISTANT. THE CUSTOMER RETESTED THE STRAIN AND OBTAINED THE SAME SUSCEPTIBLE RESULT, MIC = 2. THERE IS A LIMITATION FOR FLU02N ON THE YS08 CARD AGAINST C. GLABRATA THAT STATES: PERFORM AN ALTERNATIVE METHOD OF TESTING PRIOR TO REPORTING OF RESULTS. HOWEVER, THIS CUSTOMER IS RUNNING SOFTWARE VERSION 7.01. THERE WAS NO DEFAULT BIOART RULE IN THIS VERSION FOR THE CANDIDA GLABRATA LIMITATION. A MAR HAS BEEN ISSUED INSTRUCTING CUSTOMERS TO ADD A BIOART RULE FOR THIS LIMITATION. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOM?RIEUX INTERNAL INVESTIGATION WILL BE INITIATED.