VITEK? 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT 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 2017-01-23 for VITEK? 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT 21346 manufactured by Biomerieux, Inc.

Event Text Entries

[65579315] Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[65579316] A customer in (b)(6) reported the occurrence of a neisseria oralis strain as neisseria meningitidis in association with the vitek? 2 neisseria-haemophilus (nh) id test kit. Two repeat tests obtained the same result. The neisseria oralis identification was obtained via 16s rrna full sequencing. The customer also tested via vitek? Ms and obtained a result of neisseria mucosa. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse impact to the patient's state of health. Internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5


[75216948] A customer reported a misidentification of a neisseria oralis strain as neisseria meningitidis in association with the vitek? 2 neisseria-haemophilus (nh) id test kit (udi (b)(4)). The customer submitted the isolate for evaluation. An investigation was performed. The submitted isolate was subcultured and nh testing included two cards from two random lots, as the customer's lot was expired. The 16s sequencing was also performed. A very good identification of neisseria meningitidis was obtained twice and low discrimination identification of n. Cinerea/n. Meningitidis/n. Sicca, twice, duplicating the customer's results. The 16s sequencing resulted in 99% identity match as neisseria oralis. The product information states testing of unclaimed species may result in an unidentified result or a misidentification. Newly described or rare species may not be included in the nh database. Selected species will be added as strains become available. Neisseria oralis is not a claimed species for the vitek? 2 nh card.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1950204-2017-00027
MDR Report Key6270683
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-01-23
Date of Report2017-05-02
Date Mfgr Received2017-04-04
Device Manufacturer Date2015-04-17
Date Added to Maude2017-01-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
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 CityST. LOUIS MO 63042
Manufacturer CountryUS
Manufacturer Postal Code63042
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVITEK? 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT
Generic NameVITEK? 2 NH ID TEST KIT
Product CodeJTO
Date Received2017-01-23
Catalog Number21346
Lot Number245359410
ID Number03573026144357
Device Expiration Date2016-10-16
OperatorHEALTH PROFESSIONAL
Device Availability*
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 2017-01-23

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