• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 NH TEST KIT VITEK® 2 NH TEST CARD

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMERIEUX, INC VITEK® 2 NH TEST KIT VITEK® 2 NH TEST CARD Back to Search Results
Catalog Number 21346
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A customer in (b)(6) reported to biomérieux a misidentification of neisseria oralis as neisseria meningitides in association with the vitek® 2 nh test kit. The strain was isolated from chocolate agar and tested three times with vitek® 2 nh which identified the isolate as neisseria meningitides. The neisseria oralis identification was obtained by 16s rrna full sequencing. The customer also tested the isolate with vitek® ms and obtained a result of neisseria mucosa. There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health. The test reports were requested from the customer. An internal biomérieux investigation has been initiated.
 
Manufacturer Narrative
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 ((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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVITEK® 2 NH TEST KIT
Type of DeviceVITEK® 2 NH TEST CARD
Manufacturer (Section D)
BIOMERIEUX, INC
595 anglum road
st. louis MO 63042
Manufacturer (Section G)
BIOMERIEUX, INC
595 anglum road
st. louis MO 63042
Manufacturer Contact
ellen weltmer
595 anglum road
st. louis, MO 63042
3147317301
MDR Report Key6309212
MDR Text Key66765372
Report Number1950204-2017-00045
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K942587
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/16/2016
Device Catalogue Number21346
Device Lot Number245350210
Other Device ID Number03573026144357
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/15/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-