VITEK? 2 AST-YS07 TEST KIT 414967

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 2018-01-24 for VITEK? 2 AST-YS07 TEST KIT 414967 manufactured by Biomerieux, Inc..

Event Text Entries

[98292522] A customer in (b)(6) notified biom? Rieux of a false susceptible result when testing an external quality assessment (eqa) candida guilliermondii strain from labquality (eqa round 4 2017 - specimen s001) for antifungal susceptibility with vitek? 2 ast-ys07 (ref 414967). The customer had tested the eqa sample for identification and obtained candida guilliermondii as expected. When testing with the ast-ys07 card, they had obtained a minimal inhibitory concentration (mic) value of 2, indicating the fungus to be susceptible to fluconazole. The expected result was resistant. Labquality identified the strain as resistant with a mic value at 256 and another at 8 with e-test. The labquality (eqa round 4 2017) report defines specimen s001 as follows: "a yeast strain isolated from blood culture from a liver-transplant patient". There is no indication or report from the customer to biom? Rieux that the discrepant result led to any adverse event related to any patient's state of health. A biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1950204-2018-00040
MDR Report Key7215235
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-01-24
Date of Report2018-05-14
Date Mfgr Received2018-04-17
Device Manufacturer Date2016-10-31
Date Added to Maude2018-01-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. ELLEN WELTMER
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3147317301
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 AST-YS07 TEST KIT
Generic NameVITEK? 2 AST-YS07 TEST KIT
Product CodeNGZ
Date Received2018-01-24
Catalog Number414967
Lot Number2870157203
Device Expiration Date2018-05-02
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 2018-01-24

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