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U.S. Department of Health and Human Services

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

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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 Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
This report was initially submitted following notification that a customer in (b)(6) contacted biomérieux to report a misidentification of campylobacter jejuni ssp jejuni atcc® 33560¿ as campylobacter coli in association with the vitek® 2 neisseria-haemophilus (nh) identification (id) test kit. Investigational testing was performed using two atcc® 33560¿ strains (s1 and s2) submitted by the customer, as well as the internal biomérieux atcc® 33560¿ strain (s3). It should be noted that this atcc® strain is not a qc strain intended for the nh id card. Investigational testing included: vitek® ms: obtained identification to campylobacter jejuni for all three atcc® strains. Vitek® 2 nh id (customer lot 2450162203): s1 - very good identification to campylobacter coli. S2 - very good identification to campylobacter coli. S3 - very good identification to campylobacter coli. Vitek® 2 nh id (random lot 245398920): s1 - excellent identification to campylobacter coli. S2 - low discrimination between c. Coli, c. Jejuni ssp jejuni and c. Fetus ssp fetus. S3 - excellent identification to campylobacter coli. The investigation reproduced the customer results 83% of the time. The investigation concluded campylobacter jejuni ssp jejuni atcc® 33560¿ is an atypical strain for testing via the vitek® 2 nh id card. As previously noted, this atcc® strain is not a qc strain intended for the nh id card.
 
Event Description
A customer from france reported to biomérieux a misidentification of a campylobacter jejuni jejuni strain (atcc 33560 lot 111-38-1) as campylobacter coli in association with the vitek® 2 nh test kit (udi (b)(4)). The customer tested the strain at 24 and 48 hours immediately after incubation. The customer obtained a result of low discrimination and selected campylobacter jejuni jejuni without complementary testing. The second test result was campylobacter coli. The conforming quality control id was eikenella corrodens. There was no patient involvement as the customer was performing a control test for campylobacter strains. A biomérieux internal investigation will be initiated.
 
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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 
FR  
3147317301
MDR Report Key6570328
MDR Text Key247109935
Report Number1950204-2017-00155
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K842587
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 08/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/08/2018
Device Catalogue Number21346
Device Lot Number2450162203
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 Received08/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/05/2016
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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