VITEK? 2 YST TEST KIT 21343

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-08-13 for VITEK? 2 YST TEST KIT 21343 manufactured by Biomerieux, Inc..

Event Text Entries

[117289485] A customer in (b)(6) reported a misidentification of a candida inconspicua species external quality control strain (eeq abp mycologie 17-4c) in association with the vitek? 2 yst test kit. The customer tested the eeq strain from chromid? Candida media (18-24h of incubation) on the yst card and the identification was c. Krusei/c. Inconspicua (50/50%). The test was repeated from another unknown media and the result was c. Krusei (98%). There was no patient involvement as the event pertained to an external qc strain. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1950204-2018-00287
MDR Report Key7778120
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-08-13
Date of Report2018-10-23
Date Mfgr Received2018-09-27
Date Added to Maude2018-08-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. DEBRA BROYLES
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer G1BIOMERIEUX, INC.
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal Code63042
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVITEK? 2 YST TEST KIT
Generic NameVITEK? 2 YST TEST KIT
Product CodeJXB
Date Received2018-08-13
Catalog Number21343
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX, INC.
Manufacturer Address595 ANGLUM ROAD HAZELWOOD MO 63042 US 63042


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-13

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