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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT VITEK® 2 NH ID TEST KIT

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BIOMERIEUX, INC VITEK® 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT VITEK® 2 NH ID TEST KIT Back to Search Results
Catalog Number 21346
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Device not returned to manufacturer.
 
Event Description
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 biomérieux that the discrepant result led to any adverse impact to the patient's state of health. Internal biomérieux investigation will be 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 (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.
 
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Brand NameVITEK® 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT
Type of DeviceVITEK® 2 NH ID TEST KIT
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
hazelwood, MO 63042
3147317301
MDR Report Key6270683
MDR Text Key65579315
Report Number1950204-2017-00027
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
PMA/PMN Number
K842587
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
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 Received01/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/16/2016
Device Catalogue Number21346
Device Lot Number245359410
Other Device ID Number03573026144357
Was Device Available for Evaluation? No Answer Provided
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 Manufactured04/17/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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