VITEK? 2 NH TEST CARD 21346

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 2017-04-13 for VITEK? 2 NH TEST CARD 21346 manufactured by Biomerieux, Inc.

Event Text Entries

[72677529] A customer in france notified biom? Rieux of a discrepant result associated with vitek? 2 nh test kit. The customer performed two methods : they used the strain after 18-24 hours of incubation and after 48 hours of incubation. For each incubation, the results of the atcc strain were non-conforming. The result obtained was neisseria cinerea instead of neisseria (b)(6) the neisseria (b)(6) atcc 19424 has not to be tested systematically with the nh test kit. There is no indication or report from the hospital to biom? Rieux that the discrepant result led to any adverse event related to a patient's state of health. The strain in question is an internal quality control sample. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1950204-2017-00117
MDR Report Key6489449
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-04-13
Date of Report2017-07-10
Date Mfgr Received2017-06-13
Date Added to Maude2017-04-13
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 ContactMS. ELLEN WELTMER
Manufacturer Street595 ANGLUM ROAD
Manufacturer CitySAINT LOUIS MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer G1BIOMERIEUX, INC
Manufacturer Street595 ANGLUM ROAD
Manufacturer CitySAINT LOUIS MO 63042
Manufacturer CountryUS
Manufacturer Postal Code63042
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVITEK? 2 NH TEST CARD
Generic NameVITEK? 2 NH TEST CARD
Product CodeJTO
Date Received2017-04-13
Model Number21346
Lot Number245390220
Device Expiration Date2017-08-20
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX, INC
Manufacturer Address595 ANGLUM ROAD SAINT LOUIS MO 63042 US 63042


Patients

Patient NumberTreatmentOutcomeDate
10 2017-04-13

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