FDA.reportPublic FDA data

MAUDE MDR 7522627

MDR report key
7522627
Report number
1950204-2018-00188
Event key
0
Event type
3
Date received
2018-05-17
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
MS. DEBRA BROYLES
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.JSP213472440223403R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-05-170

Event Narratives#

D

Patient 1

A CUSTOMER FROM ITALY REPORTED A MISIDENTIFICATION OF A CLOSTRIDIUM SPOROGENES (ATCC? 11437) INTERNAL QUALITY CONTROL STRAIN AS LOW DISCRIMINATION ORGANISM IN ASSOCIATION WITH THE VITEK? 2 ANC TEST KIT. THE CUSTOMER STATED THAT THE ANC CARD GAVE A LOW DISCRIMINATION ORGANISM RESULT FIVE TIMES. THE CUSTOMER HAD PERFORMED ONE QC WHICH WAS COMPLIANT. THE CUSTOMER USED CBA MEDIUM FOR 24 HOURS THEN SUBCULTURED AND INOCULATED THE STRAIN ON ANC CARDS. THE GRAM STAIN WAS GRAM POSITIVE BACILLI. THE CUSTOMER HAD CLEANED THE OPTICS AND THE VITEK SYSTEM DID NOT GIVE ANY ERRORS. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT PERTAINED TO A QUALITY CONTROL STRAIN. THE INSTRUCTIONS FOR USE (REF.043907-02), INDICATES THE ATCC 11437 C. SPOROGENES STRAIN IS NOT RECOMMENDED FOR ANC CARDS. A BIOM?RIEUX INTERNAL INVESTIGATION WILL BE INITIATED.