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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 the (b)(6) reported to biomérieux a misidentification of campylobacter jejuni as neisseria cinerea for nine (9) strains in association with the vitek® 2 nh id test kit (udi (b)(4)). An internal biomérieux investigation was performed. The customer reported testing the isolate from columbia blood agar and incubating the organism in 10% co2. The customer stated all other testing recommendations were followed. However, vitek® 2 nh id labeling does not recommend testing campylobacter from 10% co2, and only recommends testing from strains incubated in a micro aerobic environment. Two (2) lab reports were submitted. Both lab reports showed an identification of (b)(6). One (1) lab report had six (6) atypical negative reactions (odc, pyra, ops, pvate, dmlt, lglm) and the other had 5 atypical negative reactions (odc, pyra, pvate, dmlt, lglm) for an identification of camplobacter jejuni according to the vitek® 2 nh knowledge base. Raw data was analyzed for one (1) card and reviewed. The card was tested from nh id lot # 245390220 and gave an identification of neisseria cinerea. There were six (6) atypical negative reactions (odc, lglm, pyra, ops, dmlt, pvate). All growth curves indicated no growth in these wells. An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain. Without the strain, it's not possible to further evaluate the cause of the organism misidentification. Evaluation of the manufacturing batch records for vitek® 2 nh id lots 245390220 and 245369520 indicate both lots met final qc release criteria. There were no issues on the initial qc performance testing. No ncmr was written against these lots. Ncmrs were reviewed for the last 13 months. No ncmrs were written for (b)(6) id.
 
Event Description
A customer from the (b)(6)reported to biomérieux a misidentification of campylobacter jejuni as neisseria cinerea for nine (9) strains in association with the vitek® 2 nh test kit (udi (b)(4)). The customer reported nine strains were identified as neisseria cinerea with vitek® 2 nh. One of the nine strains was sent to the reference laboratory and was identified as campylobacter jejuni, using the api® system. The customer reported the event did not involve a patient or healthcare provider and did not impact any treatment. 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. 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 63042
3147317301
MDR Report Key6552365
MDR Text Key247120624
Report Number1950204-2017-00150
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeUP
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 09/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/20/2017
Device Catalogue Number21346
Device Lot Number245390220
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 Received08/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/19/2016
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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