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 2017-02-16 for VITEK? 2 AST-YS07 TEST KIT 414967 manufactured by Biomerieux, Inc.

Event Text Entries

[67661187] A customer from (b)(6) reported to biom? Rieux a susceptibility issue for fluconazole with four (4) candida albican urine samples in association with the vitek? 2 ast-ys07 test kit. The customer tested four (4) patient isolates on three (3) vitek? Instruments with test results ranging from susceptible to resistant (mic < 0. 12 to 32). The customer also tested the isolates with an alternative method and the results were susceptible. The customer reported a delay in reporting results due to retests. They were uncertain if a wrong result was reported to a physician as they did not know which result was correct in some cases. The customer reported that a patient was not harmed or treated incorrectly. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. The isolates and test reports were requested from the customer. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1950204-2017-00055
MDR Report Key6337316
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-02-16
Date of Report2017-07-12
Date Mfgr Received2017-06-16
Device Manufacturer Date2016-09-29
Date Added to Maude2017-02-16
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 CityST. LOUIS MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3147317301
Manufacturer G1BIOMERIEUX, INC
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityST. LOUIS 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 CARD
Product CodeNGZ
Date Received2017-02-16
Catalog Number414967
Lot Number2870125203
Device Expiration Date2018-03-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX, INC
Manufacturer Address595 ANGLUM ROAD ST. LOUIS MO 63042 US 63042


Patients

Patient NumberTreatmentOutcomeDate
10 2017-02-16

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